BIIB - Biogen asked to submit internal documents by lawmakers in the probe of Alzheimer's drug

drnadig/iStock via Getty Images U.S. lawmakers investigating the controversial FDA approval granted for Alzheimer’s therapy Aduhelm (aducanumab) have asked Biogen (BIIB) to submit years of internal documents related to the drug’s development and the company’s interactions with the regulators. In June, Biogen and Eisai's (ESALF) won FDA approval for Aduhelm, making the treatment first Alzheimer’s therapy greenlighted in the U.S. in almost two decades. However, the concerns over the approval process and the therapy’s price tag prompted a probe by lawmakers leading to the appointment of two House committees to investigate the issues. According to Bloomberg, the legislators have asked the company to respond by June 26 with documents from 2018 linked to information such as the development of the drug, communications with the regulators, and strategies for pricing and commercialization. “We are concerned by reports of an atypical approval process for Aduhelm amid significant questions about the drug’s clinical benefit, and

For further details see:

Biogen asked to submit internal documents by lawmakers in the probe of Alzheimer’s drug