The FDA’s accelerated approval of Biogen Inc.’s Alzheimer’s disease therapy, Aduhelm (aducanumab), is the first real beacon of hope in 18 years for the 50 million people living with the disease. But the approval was met with controversy over the drug’s efficacy and pricing. Even as Biogen readies to launch in just two weeks with more than 900 sites lined up to start treating patients, a required confirmatory study could sink everything. In this episode, News Editor Michael Fitzhugh talks with Ivana Rubino, Biogen’s VP of global and U.S. medical affairs for Alzheimer’s disease, about the approval, the controversies and what it all means for Biogen’s future.
The BioWorld Insider Podcasts provides timely and focused one-on-one interviews with the same key sources typically interviewed for articles such as company founders, executives, top researchers and regulators. Topics are prioritized based on the same criteria we use when selecting news to feature in BioWorld, which for more than 30 years reports the breaking news — and provides key perspective — on hundreds of therapeutics and devices in development, the companies behind those candidates, the business development transactions that evolve the markets, and the regulatory hurdles that both challenge and guard the processes.