Biogen was a shattered biotech company in March after it pulled the plug on its new Alzheimer's drug, but it recaptured Wall Street's good graces by looking at its data again and deciding to shoot for FDA approval after all.
Reality check: Alzheimer's affects almost 6 million Americans, and those patients and their families have desperately sought an effective treatment. But independent experts have not reviewed Biogen's data, and the industry isn't exactly on good footing right now when it comes to being forthright about its data.
What they're saying: Many stock traders are skeptical of Biogen's new Alzheimer's claims, Stat reported.
- One of the two large clinical trials still failed.
- Everything depends on whether patients actually improved their cognitive functions on higher doses of the drug, called aducanumab.
Yes, but: That skepticism doesn't mean the drug won't get FDA approval.
- The FDA has shown a willingness recently to approve drugs, sometimes controversially, if they treat conditions with a dearth of options and if companies agree to conduct post hoc studies.
The big picture: The public should always be skeptical of drug company data and claims — especially with this drug, and in the industry's current state.
- Any drug treating Alzheimer's would greatly alter society, both clinically and financially, so there's a lot of pressure to get something like this right.
- There's also a lot of pressure to make sure drug companies aren't manipulating the results. Novartis recently got approval for Zolgensma, the world's most expensive drug, but the FDA later found out the company's data was faulty — and Novartis knew about it.