Biogen Says BLA For Lecanemab Gets Priority Review By NMPA In China

Eisai Co., Ltd. and Biogen Inc. (BIIB) Tuesday said the Biologics License Application (BLA) for lecanemab, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Lecanemab is an investigational anti-amyloid beta (Aß) protofibril antibody for the treatment of patients with early Alzheimer disease.

In January this year, the FDA had granted accelerated approval for lecanemab, marketed as LEQEMBI in the U.S, to treat patients with mild cognitive impairment or mild dementia due to Alzheimer disease.

A marketing authorization application (MAA) to the European Medicines Agency (EMA) was also submitted in January.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Elon Musk's brain implant firm Neuralink said it has received approval from the U.S. Food and Drug Administration to conduct first-in-human clinical trials. In a tweet, Neuralink said, "We are excited to share that we have received the FDA's approval to launch our first-in-human clinical study! T.W. Garner Food Co. is recalling 50,688 bottles of 12 oz. Texas Pete Buffalo Wing Sauce citing undeclared soy, the U.S. Food and Drug Administration said. The agency noted that some of the bottles may contain Texas Pete Extra Mild Wing Sauce which contains soy. The recall involves Texas Pete Buffalo Wing Sauce with best used by 120623T 065239 UPC 0 75500 10011 6. The U.S. Food and Drug Administration approved Pfizer Inc's COVID-19 oral antiviral pill Paxlovid for the treatment of mild-to-moderate COVID-19 in adults. Paxlovid is the first oral treatment, and the fourth drug, approved by the agency to treat COVID-19 in adults. Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) has been approved to treat adults who are at high...
Follow RTT