Analysts: FDA delay is a good sign for Biogen's Alzheimer's drug - Business Insider

  • 📰 BusinessInsider
  • ⏱ Reading Time:
  • 27 sec. here
  • 2 min. at publisher
  • 📊 Quality Score:
  • News: 14%
  • Publisher: 51%

Colombia Noticias Noticias

The FDA is delaying a controversial Alzheimer's drug decision. Analysts say that's a good sign.

Outside experts have said data from two halted trials don't prove the drug is effective.Visit Business Insider's homepage for more storiesThe Food and Drug Administration is delaying its decision deadline for Biogen and Eisai's hotly debated Alzheimer's disease drug, a move that analysts said bodes well for Biogen.

Biogen attributed the change to new data and analysis it had provided to regulators, which was considered a"major amendment" to its application. But, the companies' two Phase 3 trials were temporarily shut down in 2019 after a futility analysis showed they were likely to fail. Biogen revived the drug after exploring data from one of the trials further and concluding that a subset of participants had benefited from aducanumab. with the trials' opposing outcomes and the data analysis presented by Biogen.

 

Gracias por tu comentario. Tu comentario será publicado después de ser revisado.

I could use Alzheimers as the excuse to gain momentum but I would need to find the 1 out of 10 doctors that would put their career at risk by making such a diagnosis which isn't true but it's a mechanism

Analysts, like financial analysts? They care about the money, not about the cure.

No it's not

Hemos resumido esta noticia para que puedas leerla rápidamente. Si estás interesado en la noticia, puedes leer el texto completo aquí. Leer más:

 /  🏆 729. in CO

Colombia Últimas Noticias, Colombia Titulares