Merck KGaA, Pfizer Lead Drug Approval News

A roundup of the latest drug approval news, including from the pharmaceutical majors, featuring news, with news from Merck KGaA and Pfizer.

Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 10, 2017 to Tuesday May 16, 2017.

Merck KGaA, Pfizer Receive FDA Approval for Bladder Cancer Drug
EMD Serono, the biopharmaceutical business of Merck KGaA in the US and Canada, and Pfizer have received approval from the US Food and Drug Administration for Bavencio (avelumab) Injection for the treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Bavencio was previously granted accelerated approval from the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.

Avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, is part of the immunotherapy alliance that Pfizer and Merck KGaA formed in November 2014 under which the companies will collaborate on up to 20 high priority immuno-oncology clinical development programs, including combination trials. The clinical development program for avelumab involves study of more than 15 tumor types, including breast cancer, gastric/gastroesophageal cancer, head and neck cancer, Merkel cell carcinoma (an aggressive form of skin cancer), mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma, and urothelial (e.g. bladder) cancer. In November 2016, that the US Food and Drug Administration accepted for priority review a biologics license application for avelumab seeking approval for use in patients with metastatic Merkel cell carcinoma,

Source: Merck KGaA

Mitsubishi Tanabe Pharma Gets FDA OK for Drug to Treat Lou Gehrig’s Disease
Mitsubishi Tanabe Pharma America has received approval from the US Food and Drug Administration for Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig’s disease. Radicava is an intravenous infusion given by a health care professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free.The FDA granted this drug orphan drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

Source: FDA and Mitsubishi Tanabe Pharma

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