Cipla Limited announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI.
A novel formulation of the prostate cancer drug abiraterone acetate - currently marketed as Zytiga - will dramatically improve the quality of life for people suffering from prostate cancer, as pre-clinical trials by the University of South Australia show the new formulation improves the drug's effectiveness by 40 per cent.
Caption : A novel formulation of the prostate cancer drug abiraterone acetate - currently marketed as Zytiga - will dramatically improve the quality of life for people suffering from prostate cancer. Credit : Hayley Schultz/UniSA
New research indicates that taking vitamin D supplements may help prevent a potentially serious side effect of a revolutionary form of anti-cancer therapy. The findings are published early online in CANCER, a peer-reviewed journal of the American Cancer Society (ACS).
Hetero, one of India’s leading generic pharmaceutical companies, announced today that it has received the manufacturing and marketing approval for the investigational antiviral medicine ‘Remdesivir’ from the Drug Controller General of India (DCGI) for the treatment of Covid-19. Hetero’s generic version of Remdesivir will be marketed under the brand name ‘COVIFOR’ in India.
Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies, commented: “In the light of increasing COVID-19 cases in India, the approval of ‘COVIFOR’ (Remdesivir) can prove to be a game-changer given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country. We are prepared for ensuring enough stocks required to cater to the present needs. We will continue to work closely with the government and medical community to make a difference in the fight against COVID-19. This product is made indigenously in line with ‘Make in India’ campaign as envisioned by our Hon’ble Prime Minister.”
The drug ‘Remdesivir’ has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalized with severe symptoms of the disease. COVIFOR (Remdesivir) will be available in 100 mg vial (Injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner.
The product is launched under a licensing agreement with Gilead Sciences Inc. to expand access to COVID-19 treatment in low and middle-income countries.
In a landmark development for COVID-19 patients in India, Glenmark Pharmaceuticals got approval of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19.
Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart diseasewith mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement.Of most importance, Favipiravir has shown clinical improvementof up to 88% in COVID-19 mild to moderate COVID 19 cases.
Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team.Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients.
Commenting on the significance of this development, Mr. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals Ltd., said, “This approval comes at a time when cases in India are spiralling like never before,putting a tremendous pressure on our healthcare system. We hope the availability of an effective treatment such as FabiFlu® will considerably help assuage this pressure, and offer patients in India a much needed and timely therapy option.”
He added, “FabiFlu® has demonstrated an encouraging response in mild to moderate COVID-19 patients during clinical trials. Moreover, it is orally administered, and so it serves as a more convenient treatment option over other intravenously administered medications. Glenmark will work closely with the government and medical community to make FabiFlu® quickly accessible to patients across the country.”
Favipiravir is approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity.
Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use.The drug will be available as a prescription-based medicationfor INR 103/tablet,with recommended dose being1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.
Earlier last month, Glenmark also announced that it is conducting another clinical trial to evaluate the efficacy of two antivirals Favipiravir and Umifenovir as a combination therapy in moderate hospitalized adult COVID-19 patients in India.
Amidst ever-increasing cases of coronavirus, efforts are being made to speed up testing of suspects of COVID-19 carriers, especially in the interior parts of the country. In one such initiative, a mobile diagnostic unit I-Lab (Infectious disease diagnostic lab) has been launched on Thursday by Dr. Harsh Vardhan, Minister of Science and Technology, Health and Family Welfare and Earth Sciences. The I-Lab is expected to help in the expansion of COVID-19 testing in remote areas.
Accurate testing is important to get out of the clutches of novel coronavirus. Steeping up efforts in this regard, the Indian Institute of Technology (IIT) Guwahati, in association with RR Animal Healthcare Ltd and Guwahati Medical College and Hospital (GMCH), has developed low-cost diagnostic kits. These are Viral Transport Media (VTM) kits, RT-PCR kits, and RNA isolation kits. Himanta Biswa Sarma, the Minister of Finance, Health and Family Welfare, Assam, launched the VTM kits.
The Central Drug Research Institute (CDRI), Lucknow, has received permission from Drug Controller General of India (DCGI) for carrying out Phase III clinical trials to test the efficacy, safety and tolerability of the antiviral drug Umifenovir. The Phase III activities will be carried out at King George's Medical University (KGMU), Dr Ram Manohar Lohia Institute of Medical Sciences (RMLIMS) and ERA's Lucknow Medical College and Hospital, Lucknow.
CLICK HERE TO SUBSCRIBE,
PHARMATUTOR's DAILY EMAILS
Do Not Forget to Verify
(Click on Subscription link in your inbox)
--------
