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
sy.mukherjee@fortune.com
@the_sy_guy
DIGITAL HEALTH
Facebook plots a smartwatch with health tech features. Apple, Garmin, Android watches - they're all united in breaking into the health care space with splashy new tools like heart rate monitors built into their devices. Enter another tech giant: Facebook. The Verge reports that the company has high ambitions for a wearable smartwatch franchise that can monitor biometrics and also comes equipped with high resolution cameras for video calls. Whether this all comes to fruition, and how successful the effort may be, is a separate question given the dominance Apple and other smartwatch makers have already established in the space. (The Verge)
INDICATIONS
The implications of Biogen's Alzheimer's drug indications. A drug approval has ripple effects, as we've established, in how companies interact with regulators. But there are also broader policy implications when it comes to a treatment like Biogen's Alzheimer's drug Aduhelm. For instance, given the $56,000 per year list price Biogen has planned for the treatment, the sprawling Medicare program for the elderly could pay a hefty price, according to an analysis by the Kaiser Family Foundation. “If 1 million Medicare beneficiaries receive Aduhelm, which may even be on the low end of Biogen’s expectations, spending on Aduhelm alone would exceed $57 billion dollars in a single year—far surpassing spending on all other Part B-covered drugs combined,” the report states. (CNBC)
THE BIG PICTURE
President Biden's 500 million dose vaccine-sharing plan. The Biden administration announced plans to donate 500 million doses of COVID-19 vaccines procured by the United States in a press conference alongside Pfizer CEO Albert Bourla on Thursday. The U.S. has faced criticism from developing nations for not being aggressive in COVID vaccine-sharing efforts. Previously, in an effort to combat the narrative of vaccine nationalism, and to boost a global immunization campaign in a critical moment, the Biden administration announced that it will donate 75% of unused COVID vaccines in the U.S. to COVAX, the worldwide vaccine sharing program. That includes plans to share 80 million COVID vaccine doses by the end of the month, as we previously reported. (Fortune)
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