USFDA

US Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 12 to 1 that the data presented support the use of Entresto® (sacubitril/valsartan) in treatment of patients with heart failure with preserved ejection fraction (HFpEF). This was based on data supporting the benefit of Entresto in reducing worsening heart failure (total heart failure [HF] hospitalizations and urgent HF visits) in patients studied in PARAGON-HF. If approved by the FDA, Entresto could become the first therapy indicated for use in treatment of patients with HFpEF, as well as the first medication approved for both major types of chronic heart failure, HFpEF and heart failure with reduced ejection fraction (HFrEF), both based on trials that included active comparators (valsartan and enalapril, respectively).

With no approved therapies for HFpEF to address the prevention of HF hospitalizations and urgent visits, a significant unmet medical need exists for a treatment to reduce the burden associated with this debilitating condition. The FDA is expected to make a decision on the supplemental New Drug Application (sNDA) in the first quarter of 2021.

“Managing HFpEF has historically been a clinical and scientific challenge due to the heterogeneity of the condition,” said Scott Solomon, MD, Professor of Medicine at Harvard Medical School and Brigham and Women's Hospital, and PARAGON-HF Executive Committee Co-Chair. “Today’s vote represents much needed progress in this area of unmet need and is a positive step toward bringing a potential therapy to millions of patients suffering from this type of heart failure.”

The Committee’s positive decision is based on the totality of evidence from efficacy and safety analyses, including findings presented from a pre-specified subgroup analysis of PARAGON-HF, the largest and only Phase III active-controlled study to date in patients with HFpEF and additional evidence from PARAMOUNT (a Phase II trial in HFpEF), as well as PARADIGM-HF (a Phase III trial in HFrEF). Data from PARAGON-HF demonstrated a favorable safety profile for Entresto in patients with HFpEF, which is in line with the vast clinical and post-marketing experience in HFrEF, and showed clinical benefit of Entresto in HFpEF patients.

“Our commitment to reimagine medicine through our extensive clinical trials program on heart failure has been unwavering, and we are encouraged by the Committee’s response today,” said David Soergel, MD, Global Head of Cardiovascular, Renal and Metabolic Drug Development, Novartis. “We appreciate the valuable insights shared by the patient and advocacy community about this devastating disease, and we look forward to FDA’s decision on the potential approval of this new indication.”

HFpEF affects more than 3 million Americans, and is increasing in prevalence as the population ages. It is a complex disease for which it is difficult to develop treatments due to its heterogeneous pathophysiology and the varied impact of symptoms among patients, despite decades of research. HFpEF can change the structure of the heart and occurs when the muscle tissue of the heart thickens and stiffens so that it cannot expand to fill with enough blood to meet the body’s needs. HFpEF is associated with high rates of recurring heart failure hospitalizations, emergency room visits and urgent doctor’s office appointments. Each hospitalization event is associated with worsening long-term prognosis, and approximately one in four patients are re-admitted for heart failure within one year of discharge.

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Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 200 μg/50 mL and 400 μg/100 mL Single Dose flexible containers (Bags).

Aurobindo’s Dexmedetomidine HCl in 0.9% Sodium Chloride Injection is a therapeutic equivalent generic version of Hospira’s Precedex® in 0.9% Sodium Chloride Injection. The product will be launched in January 2021.

Dexmedetomidine Hydrochloride in 0.9% sodium chloride injection is a relatively selective alpha2 -adrenergic agonist indicated for a) sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting; b) sedation of non-intubated patients prior to and/or during surgical and other procedures. The approved product has an estimated market size of US$ 228 million for the twelve months ending October 2020 according to IQVIA.

This is the 79th ANDA to be approved out of Unit IV formulation facility in Hyderabad, India used for manufacturing injectable & ophthalmic products. Aurobindo now has a total of 459 ANDA approvals (431 Final approvals and 28 tentative approvals) from USFDA.

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Pharma major Lupin Limited (Lupin) announced that it has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depen® Tablets, 250 mg, of Mylan Specialty, L.P. The product would be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly.

Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy.

Penicillamine Tablets USP (RLD: Depen®) had an annual sales of approximately USD 4 million in the U.S. (IQVIA MAT September 2020).

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Applied DNA Sciences, Inc a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing, announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) amendment that expands the installed base of RT-PCR platforms that can process the Company’s Linea™ COVID-19 Assay Kit. The EUA amendment extends the RT-PCR platform authorization from Applied Biosystems’ (ThermoFisher Scientific) QuantStudio™ Dx and QuantStudio™ 5 Real-Time PCR systems to include Applied Biosystems™ 7500 Fast Dx Real-Time PCR System (ABI 7500). The ABI 7500 has the capacity to perform 400 – 800 tests in 24 hours and is found in the majority of clinical laboratories nationally.

“With this amendment to our EUA, we significantly increase the number of authorized devices on which our assay kit can run and remove a gating factor to the more widespread adoption of our high sensitivity test,” said Dr. James A. Hayward, president and CEO, Applied DNA. “We are actively engaged with clinical laboratories nationally with which our opportunities for assay kit contracts are bolstered by the addition of an RT-PCR system in wide use by the diagnostics industry. Additional planned amendments, we believe, will further differentiate our assay in the marketplace and to operators of clinical diagnostic labs.”

Update on Applied DNA Clinical Laboratories CLEP-CLIA Certification

Separately, the Company announced that an inspection report from the State of New York Department of Health (DoH) following the DoH’s initial inspection of Applied DNA Clinical Laboratories, LLC (ADCL) on October 7, 2020, highlighted deficiencies in ADCL’s clinical standard of practice at the time of inspection that require remediation prior to the submission of a re-inspection request. The Company expects to complete remediation actions during the first calendar quarter of 2021. In the interim, ADCL’s safeCircle™ platform, its pooled COVID-19 surveillance testing program that does not require CLEP-CLIA certifications, is leveraging infrastructure designated for diagnostic testing to support safeCircle clients and Applied DNA’s internal surveillance testing program for employees.

“While disappointed with the push-out in our CLEP-CLIA certification timeline, our pooled surveillance testing platform can generate more revenue per pooled sample comprising 5 individuals than from the diagnostic testing of 1 individual in the same amount of time and using the same personnel, procedures, and equipment,” concluded Dr. Hayward. “Surveillance testing is readily scalable, and in recent weeks, we have concentrated our efforts on ramping up surveillance testing capacity. Our sales efforts are focused on tapping into the need for consistent, ongoing, and high sensitivity PCR-based COVID-19 testing that is becoming as foundational to stopping the spread of the virus as masks, handwashing, and social distancing. We believe the value of our safeCircle platform is that its sensitivity allows our clients to identify and isolate infected populations early – in many cases before population members suspect they are ill – to help break the chain of transmission that could otherwise fuel the exponential growth of COVID-19.”

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Zydus Cadila has received final approval from the USFDA to market Solifenacin Succinate Tablets, (US RLD:  Vesicare®Tablets)  in  the  strengths  of5  mg  and  10  mg.  Solifenacin  Succinateis  a  symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.

The group now has 309 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04.

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Dr. Reddy’s Laboratories Ltd announced the launch of over-the-counter (OTC) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1%, the storebrand equivalents of Pataday® Once Daily Relief and Pataday® Twice Daily Relief, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% and 0.1% are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander. The Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is also indicated for the temporary relief of red eyes.

“This launch marks the entry of Dr. Reddy’s into the OTC eye care space, and is a testament to our deep capabilities in bringing store-brand equivalents of Rx-to-OTC switches to the U.S. market,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “We are very excited to extend our strategic collaboration with Gland Pharma to bring these products to the market. We thank the teams at Gland and Dr. Reddy’s whose hard work and efforts have enabled the execution of this launch in such a short timeframe.”

The Pataday® brand had U.S. sales of approximately $31 million since the launch in March 2020 according to IRi*.

Dr. Reddy’s Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is available in a 2.5 mL bottle and Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is available in a 5 mL bottle size.

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The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies. The sBLA is supported by positive results from the Phase 3 ANDROMEDA study, which were presented as a late-breaking abstract at the 25th European Hematology Association Annual Congress in June. ANDROMEDA evaluated subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone and met its primary endpoint of overall hematologic complete response rate. 

"We are excited about the potential of helping patients with AL amyloidosis who currently have no FDA-approved therapies for the treatment of their disease," said Craig Tendler, M.D., Vice President, Clinical Development and Global Medical Affairs, Oncology, Janssen Research & Development, LLC. "The results from the Phase 3 ANDROMEDA study also provide preliminary evidence of DARZALEX FASPRO's potential to modify the organ damage that is a hallmark of this serious disease with high unmet needs and we look forward to collaborating with the agency in the review of the application."

The sBLA is being reviewed under the FDA Real-Time Oncology Review (RTOR) program, which allows data for certain applications to be reviewed before the applicant formally submits the complete application. The RTOR program aims to explore a more efficient review process to help ensure treatments are available as soon as possible for patients. Selection into the RTOR program does not guarantee or influence approvability of the supplemental application.

The submission is also being reviewed under Project Orbis, an initiative of the FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicine applications among international regulatory agencies.

AL amyloidosis is a life-threatening disorder that occurs when plasma cells in the bone marrow produce abnormal light chains, that form amyloid deposits, which build up in vital organs and eventually cause organ deterioration. The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, GI tract and nervous system. Diagnosis of AL amyloidosis is often delayed because patients present with non-specific symptoms that mimic other conditions, resulting in a poor prognosis. There are currently no FDA-approved therapies to treat this devastating disease. While AL amyloidosis is the most common type of amyloidosis, it remains a rare disease with an estimated 30,000 to 45,000 people living with the disease in the U.S. and Europe. Each year, an estimated 4,500 people develop AL amyloidosis in the U.S. alone.

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Strides Pharma Science Limited (Strides) stated that its wholly-owned step-down subsidiary, Strides Pharma Global Pte. Limited, Singapore, has secured the approval of the United States Food & Drug Administration (USFDA) for Prednisone Tablets USP, 1 mg. These tablets are a generic version of Schering Corporation’s Meticorten Tablets, 1 mg.

As per the IQVIA MAT July 2020 figures, the US market ranges up to USD 12 million for Prednisone Tablets USP, 1 mg. According to the company’s press release, the manufacturing of the tablet will take place at the flagship facility of the company at Bengaluru. The tablets will be sold in the US market by Strides Pharma Inc. 

Recently on August 21, 2020, Strides Pharma Science Limited got the USFDA approval for Ursodiol Tablets USP, 250 mg and 500 mg also. During February, Strides’ wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, signed a comprehensive asset transfer and licensing agreement with Pharmaceutics International, Inc. to obtain 18 ANDAs from the company for the US market. Strides aim to expand its niche offerings significantly on its front end, that will lead to multi fold growth in the upcoming years.

As per the consolidated unaudited financial reports of the company for the quarter ended June 30, 2020, the company’s total income was INR 7,941.02 million as compared to the INR 6,960.52 million of the corresponding quarter of the previous year. The profit before tax for the above-mentioned quarter stands at INR 1,051.25 million which is much higher than INR 248.84 million of the corresponding quarter of the previous year.

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Baxter International Inc a global innovator in renal care, announced the U.S. Food and Drug Administration (FDA) has granted the De Novo application for Theranova, the company’s novel dialysis membrane. Theranova was designed to deliver expanded hemodialysis (HDx) therapy, which filters a wider range of molecules from the blood than traditional hemodialysis (HD) filters, like high-flux membranes, by targeting effective removal of conventional (500 Da to 25 kDa) and large middle molecules (25 kDa to 45 kDa). These middle molecules may be associated with inflammation and cardiovascular disease in patients with kidney failure.

By granting a De Novo application, the FDA is establishing a new class of dialyzer technology with unique performance standards. The FDA utilizes the De Novo pathway for low and moderate risk medical devices that have no existing predicate in the United States; such designations are rare in the dialysis space. In fact, less than 1% of devices granted marketing authorization under De Novo have been for the care of patients with kidney failure since the pathway’s inception in 1997.

HDx is performed the same way as conventional HD, with only a change of the dialyzer membrane required. Once in the machine, the Theranova dialyzer’s innovative Medium Cut-Off® membrane combines high permeability and selectivity for uremic toxins (up to 45 kDa), while retaining essential proteins and maintaining albumin levels during treatment2,3. This unique cut-off and high retention onset profile expands clearance, allowing for filtration closer to that of the natural kidney.

"U.S. patients on HD deserve more options than are currently available to them, and we are taking extraordinary steps to support their access to Theranova," said Gavin Campbell, general manager of Baxter's U.S. Renal Care business. "Patients are currently treated with HDx enabled by Theranova in more than 40 countries worldwide, and we are doing everything we can in the U.S. to ensure healthcare providers can also realize the full value of this therapy for their patients on HD."

To date, over 90 independent and Baxter-led or sponsored studies have been conducted on HDx therapy enabled by Theranova. The studies evaluated a range of clinical and quality-of-life measures, including the ability to clear conventional and large middle molecules, albumin retention, chronic inflammation and other side effects of standard HD therapy.

"Individually, the side effects from standard HD, which patients typically undertake three days a week, four hours per day, may seem manageable. However, the chronic effects of treatment accumulate and over time, cause some patients to give up on therapy," explained Mary Gellens, M.D., nephrologist and senior medical director at Baxter. "HDx therapy enabled by Theranova is a promising alternative to what is currently available because it delivers a filtration profile that is closer to the natural kidney."

Due to the novel nature of Theranova, Baxter conducted a randomized controlled clinical study in the United States that evaluated the safety and efficacy of HDx therapy enabled by Theranova. During the study, as reported during the 2019 American Society of Nephrology Kidney Week, 172 hemodialysis patients received therapy with either a medium cut-off dialyzer (Theranova 400) or a high-flux dialyzer (ELISIO-17H) over 24 weeks of treatment, with a primary efficacy endpoint measuring the reduction ratio of lambda (λ) free light chains at 24 weeks of treatment, while maintaining pre-dialysis serum albumin levels. Data from the study, which was just published in the Clinical Journal of the American Society of Nephrology (CJASN), found that expanded hemodialysis therapy with the Theranova 400 dialyzer provides superior removal of large middle molecules, as exemplified by λ free light chains, as compared to a similarly sized high flux dialyzer while maintaining serum albumin levels7. Large middle molecules are a diverse group of uremic toxins that are believed to contribute to the high cardiovascular disease burden in end stage kidney disease8. Dialysis technologies available to date offer limited clearance of these molecules8. The ability to efficiently remove these large middle molecules provides dialysis patients with a new alternative therapy.

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Since the outset of our discovery of impurities called nitrosamines in some types of drugs more than two years ago, the U.S. Food and Drug Administration has undertaken a thorough investigation in an effort to protect patients. While nitrosamines are common in water and foods, nitrosamine impurities may increase the risk of cancer if people are exposed to them above acceptable levels and over long periods of time. For this reason, the discovery of unexpected nitrosamine impurities in some drug products is a serious concern, and the FDA has been working, in collaboration with regulatory counterparts around the world, to find and remove drugs with unacceptable nitrosamine impurities from the U.S. drug supply. As we do so, we’re also taking proactive efforts to help ensure that in the future, drugs can be free from unsafe levels of these impurities from the start of production.

Ensuring that drugs are safe, effective and high-quality is a critical part of FDA’s mission. In our continued efforts to be transparent and provide guidance to manufacturers on how to detect and prevent unacceptable levels of nitrosamine impurities, today we’re publishing our guidance Control of Nitrosamine Impurities in Human Drugs for immediate implementation. This guidance recommends steps, including a comprehensive risk assessment strategy and other actions that manufacturers can take to reduce or prevent the presence of nitrosamine impurities in their drugs.

There are many reasons why these impurities might appear in some drugs, and consequently many approaches to screening for and preventing the appearance of nitrosamines to help ensure drug quality and safety. The source of these impurities can be related to the drug’s manufacturing process, the materials used in manufacturing, the drugs’ chemical structure, or even the conditions in which drugs are stored or packaged. Under FDA’s oversight, manufacturers are responsible for mitigating these impurities.

The most common nitrosamine impurity, N-nitrosodimethylamine (NDMA), is found at low levels in water and foods, including cured and grilled meats, dairy products and vegetables. The FDA and the international scientific community do not expect NDMA to cause harm when ingested at low levels. However, given the risk that genotoxic substances such as NDMA may increase the risk of cancer if people are exposed to them above certain levels and over long periods of time, manufacturers have recalled drugs with NDMA levels higher than the FDA’s recommended acceptable intake levels. Patients taking medications with potential nitrosamine impurities should not stop taking their medications and should talk with their health care professional about concerns and other treatment options.

We believe that the guidance we’ve issued today will assist manufacturers in preventing unacceptable levels of nitrosamines in drugs. Protecting patients is the FDA’s highest priority, and we will continue to work with manufacturers and our international regulatory partners to investigate and definitively resolve this problem.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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