AstraZeneca and Eli Lilly and Company announced that AMARANTH, a Phase II/III study of AZD3293, an oral beta secretase cleaving enzyme (BACE) inhibitor currently in development as a potential treatment for early Alzheimer’s disease, will continue into Phase III of the Phase II/III seamless trial.
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the conditional approval of Pandemic Live Attenuated Influenza Vaccine (P/LAIV). P/LAIV is indicated for the prevention of influenza in an officially declared pandemic in children and adolescents from 12 months to less than 18 years of age.
AstraZeneca confirmed that the American College of Cardiology (ACC) and American Heart Association (AHA) have released a treatment guideline on the duration of dual antiplatelet therapy (DAPT). Brilinta (ticagrelor) is now preferred over clopidogrel for the management of patients with acute coronary syndrome (ACS) who have received a coronary stent and in non-ST Elevation Acute Coronary Syndrome (NSTE-ACS) patients treated with medical therapy alone (Class IIa LoE: B-R). This update is the first time the ACC/AHA has recommended Brilinta over clopidogrel for patients who have experienced an ST-elevation myocardial infarction (STEMI).
AstraZeneca announced the top-line results of the SOCRATES trial, assessing the efficacy of Brilinta/Brilique (ticagrelor) 90mg tablets twice daily, when compared to aspirin 100mg once daily in patients with acute ischaemic stroke or transient ischaemic attack (TIA). The primary efficacy endpoint of time to first occurrence of any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction (MI, also known as heart attack) and death was not met. Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population but the trend did not reach statistical significance.
Sun Pharma and AstraZeneca Pharma India Limited announced a partnership for the distribution of dapagliflozin, an innovative Type 2 diabetes medicine, in India. Dapagliflozin is AstraZeneca India’s leading diabetes medicine.
AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for the investigational anti-CD19 monoclonal antibody, MEDI-551, for the treatment of patients with neuromyelitis optica (NMO) as well as neuromyelitis optica spectrum disorders (NMOSD). Developed by MedImmune, MEDI-551 is currently in Phase IIb clinical development for NMO.
AstraZeneca announced that it has entered into an agreement with ProStrakan Group, a subsidiary of Kyowa Hakko Kirin Co. Ltd., for the rights to Moventig (naloxegol) in the European Union (EU), Iceland, Norway, Switzerland and Liechtenstein. Moventig is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) approved in Europe for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
AstraZeneca announced it has entered into a licensing agreement with China Medical System Holdings Ltd (CMS) for the commercialisation rights in China to its calcium channel blocker, Plendil (felodipine). Plendil was first approved in China in 1995 for the treatment of hypertension or high blood pressure and in 2015 achieved Product Sales of $189 million.
AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL) and lymphoplasmacytic lymphoma (Waldenström’s macroglobulinaemia, WM).
AstraZeneca announced that the European Commission (EC) has granted marketing authorisation for ZurampicTM (lesinurad) 200mg in combination with a xanthine oxidase inhibitor (XOI) for the adjunctive treatment of hyperuricemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid (sUA) levels with an adequate dose of an XOI alone.