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The Readout Damian Garde & Meghana Keshavan

Lilly’s ready to roll the dice in Alzheimer’s

Weeks after the FDA’s surprising approval of Biogen’s polarizing treatment for Alzheimer’s disease, Eli Lilly now sees a path forward for a similar therapy of its own, accelerating its path to market by roughly two years.

As STAT’s Adam Feuerstein reports, Lilly said yesterday that it will submit its Alzheimer's treatment, donanemab, to the FDA for approval by the end of the year. The company had previously planned to wait for data from an ongoing Phase 3 trial, not expected until 2023, but the FDA’s unprecedented decision to approve Biogen’s Aduhelm opened a pathway for an earlier filing.

There’s no guarantee the FDA will accept Lilly’s application, much less approve donanemab based on the available Phase 2 data. But Lilly has a case to make. In its Aduhelm decision, the FDA determined that Biogen’s drug had an effect on toxic brain plaques that was likely to predict a clinical benefit. In Lilly’s study, which enrolled 272 patients, 68% of those who got donanemab had no detectable plaques after 18 months.

Read more.

Biogen’s windfall could be short-lived

If Eli Lilly is right and there is indeed enough evidence on donanemab to merit FDA approval, what does that mean for Biogen and those billions of dollars penciled in for Aduhelm’s future sales?

That question weighed on investors’ minds yesterday, as Biogen’s share price fell by more than 6%, cutting more than $3 billion from the company’s market value. In clinical trials, Lilly’s treatment appears to have a faster and more pronounced effect on brain plaques. And unlike Aduhelm, which is dosed once a month in perpetuity, Lilly’s treatment is administered only until amyloid plaques in patients' brains reach a certain threshold. That could make it more attractive to physicians and more cost-effective for payers.

But as Baird analyst Brian Skorney pointed out in a note to investors, if the Aduhelm approval really has set a new standard at the FDA, the implications stretch far beyond Biogen and Lilly. There are other medications with established effects on amyloid plaques and “the FDA's decision to open the floodgates” suggests each could win approval. That could force some competition on pricing, but it would almost certainly place a heavy burden on Medicare, and the final result could be legislative reform that makes such therapies far less lucrative for their manufacturers.

At least investors are happy

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The Aduhelm saga has brought rebukes for the FDA, threats from lawmakers, and familiar castigations for the drug industry. But for biotech’s otherwise ailing stock indices, it has only been positive.

The XBI, pictured above, rose more than 2% yesterday, helping biotech inch closer to where it started the year after months of consistent red tape. The Nasdaq Biotech Index is up nearly 6% since Aduhelm’s approval, and the IBB, another closely watched index, turned positive for the year after a month-long slump.

It’s worth noting that the entire sector is still down from the all-time highs set in February, when a sudden interest from generalist investors briefly made CRISPR look like the next Bitcoin. But the recent upward trend suggests the rest of the year might be less volatile.

How does the FDA handle unprecedented decisions?

What's it like to be a guest on "Good Morning America?" And does the world need a "New" GlaxoSmithKline?

We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we sift through the week's news, with a major update from Eli Lilly in Alzheimer's disease and new details on the inner workings of the FDA. Then, STAT's Matthew Herper joins us to discuss how GlaxoSmithKline ended up in a self-preservation struggle. Finally, STAT's Nicholas St. Fleur calls in to talk about the alarming rise of colorectal cancer deaths among young men and his decision to get an on-camera colonoscopy for a reporting project.

Listen here.

More reads

  • 5 companies harnessing AI for drug discovery to watch. (STAT+)
  • Oxford researchers say they developed blood test predictor of vaccine efficacy. (Reuters)
  • A crucial, overlooked question on the new Alzheimer’s drug: When should patients stop taking it? (STAT)

Thanks for reading! Until next week,

Friday, June 25, 2021

STAT

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