What comes next after the Biogen Alzheimer’s drug approval

Good afternoon, readers.

It’s cliché to toss around terms like “landmark” or “historic” in the life sciences industry. That is, unless a product truly warrants it. And the FDA’s approval of Biogen’s Alzheimer’s drug aducanumab (to be marketed under the brand name Aduhelm) this week meets that threshold.

This was one of the most closely-watched FDA decisions in decades. Why? Aducanumab is the first-ever drug that actually targets the underlying disease of Alzheimer’s rather than just its symptoms. That is, it can theoretically slow the rate of cognitive decline in a massive population of patients.

But there’s another reason. The clinical trials leading to aducanumab’s approval were controversial and even led the FDA to require a new confirmation study to see how effective the drug really is. The agency overruled the overwhelming advice of its own outside experts to green light the treatment following a concerted advocacy campaign by patient and industry-affiliated groups.

Those follow-up trials could take nine years to complete while aducanumab is on the market. And that could shake up the drug development landscape at large.

“When I speak with regulatory professionals, the people inside of companies who are charged with getting a product to approval by the FDA, the thing that they constantly ask me is, what precedent is there?” Alec Gaffney, senior director of research at AgencyIQ, an independent regulatory intelligence arm of the news site Politico, tells me.

“What examples are there of companies that have successfully obtained FDA approval? And is the process…they went through [for] that approval able to be emulated by me?”

Gaffney points out that other companies and advocates for patients who don’t have available treatments on the market can point to the aducanumab approval as a reason for fast-tracking other products even if their efficacy isn’t fully established. After all, something is better than nothing, the thinking goes.

“You’ve seen the ALS community in particular take a look at what happened with aducanumab and say, ‘Well, there are other experimental products for our disease, which is also a serious condition without adequately approved therapies for treatment,’” says Gaffney. “Can you make an approval on an accelerated basis? What do we have to do to benefit from this in the same way?”

The decision is sure to influence how drug makers in the Alzheimer’s space such as Eli Lilly and beyond interact with the FDA. But it could also lead to some soul-searching at the agency over how to balance patient needs and a laser-sharp focus on scientific evidence. For now, the FDA has decided that the benefits outweigh the risks in such a devastating disease.

Read on for the day’s news, and see you again next Thursday.

Sy Mukherjee
[email protected]
@the_sy_guy

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