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The Readout Damian Garde & Meghana Keshavan

Biogen is already getting on the FDA’s nerves

It only took a few hours for Biogen, beneficiary of a polarizing FDA decision, to irk the very regulators who forever altered its corporate fortunes.

On Monday, after the surprising FDA approval of Biogen’s Alzheimer’s disease treatment Aduhelm, CEO Michel Vounatsos told CNBC the company had nine years to complete an agency-mandated confirmatory trial. As STAT’s Adam Feuerstein and Matthew Herper report, those words didn’t go over well at the FDA, as Vounatsos’s tone suggested a lack of urgency on Biogen’s part, according to an agency official.

But Vounatsos wasn’t technically wrong. In its approval letter to Biogen, the FDA asked the company to be ready to start the study by August 2022 and to deliver final results no later than October 2030. According to the agency official, that timeline was meant to be a “conservative estimate” and a “starting point.” It’s unclear whether Biogen picked up on that message.

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The FDA’s advisers aren’t happy, either

In order to approve Aduhelm, the FDA overlooked the resounding recommendation of its independent advisers. And some of them are not terribly pleased with being ignored.

As STAT’s Andrew Joseph reports, one member of the FDA’s neurology advisory committee has resigned in protest, citing the agency’s decision to approve Biogen’s treatment without reconvening the group. Other members criticized the FDA’s decision and warned that it could set a regrettable precedent for future drug applications based on incomplete data.

What remains to be seen is whether the agency’s move to override its advisers will have a lasting impact on the regulatory process. Experts often jump at the chance to serve on FDA panels, and their existence provides the agency some political cover for controversial decisions. If would-be panelists think twice about participating, the whole system is put at risk.

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More than two-thirds of Congress cashed a pharma campaign check in 2020

That’s according to the latest edition of Prescription Politics, STAT’s regular analysis of pharmaceutical dollars shape federal policy.

As Lev Facher reports, 72 senators and 302 members of the House of Representatives received donations from drug companies ahead of the last general election, highlighting the industry’s continued clout in Washington.

Pharma spent about $14 million in aggregate. Among the most prolific donors were Pfizer, whose political action committee alone contributed to 228 lawmakers, and Amgen, whose PAC donated to 218. That means each company helped to fund the campaigns of nearly half the lawmakers on Capitol Hill.

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Biogen isn’t worried about a pricing backlash

Biogen’s decision to charge $56,000 a year for its new treatment for Alzheimer’s disease has incensed health policy experts and alarmed Wall Street analysts, but the company’s commercial leader insists it’s “a really responsible price,” and one that’s “sustainable for the system.”

On a conference call with analysts yesterday, Biogen defended the cost of Aduhelm by pointing to other antibody treatments on the market. Cancer immunotherapies like Merck’s blockbuster Keytruda cost upward of $150,000 a year, and anti-inflammatory treatments like AbbVie’s Humira go for more than $70,000 a year. By comparison, Aduhelm’s price is reasonable.

An important point, which payers are certain to make, is that Keytruda has proved time and again to extend the lives of patients with cancer, and Humira can clear up psoriasis and relieve arthritis. Aduhelm, on the other hand, just won approval based on a surrogate endpoint that might not actually predict clinical benefit. 

Read more.

More reads

  • Regeneron shareholders urged to boot board member over executive pay practices. (STAT+)
  • EU regulator does not expect approval for CureVac vaccine before August. (Reuters)
  • STAT+ Conversations: Discussing Biogen’s Alzheimer’s drug. (STAT+)
  • Alzheimer’s drug is bonanza for Biogen, most likely at taxpayer expense. (New York Times)

Thanks for reading! Until tomorrow,

Wednesday, June 9, 2021

STAT

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