Biogen admits Aduhelm launch ‘slower than we anticipated’

Biogen CEO Michel Vounatsos admitted Thursday that the launch of Aduhelm, the company’s intensely scrutinized treatment for Alzheimer’s disease, has been “slower than we anticipated,” which he blamed in part on “confusion, misinformation, and controversy” about whether the drug works and how it was approved.

Only about 50 centers around the country have administered at least one dose of Aduhelm, which won Food and Drug Administration approval on June 7, Biogen said at an investor conference sponsored by the investment bank Morgan Stanley. That has led Biogen to revisit its “already very low sales target” for 2021, Vounatsos said.

Biogen’s share price fell nearly 6% during the company’s presentation. Wall Street’s earnings estimates for Biogen implied that about 12,000 patients were receiving Aduhelm, according to Evercore ISI analyst Umer Raffat, suggesting a massive disparity between investor expectations and commercial reality. The company has lost nearly 25% of its value since Aduhelm was approved.

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Vounatsos blamed Aduhelm’s slow uptake on insufficient infrastructure to administer the infused treatment, a lack of clarity around whether payers will reimburse for it, and a pervasive misunderstanding of Biogen’s data on the drug. Physicians and scientists have questioned Aduhelm’s efficacy because it was approved based on its ability to reduce toxic plaques in the brain, not its effect on the cognitive decline that marks Alzheimer’s. Vounatsos argues that reducing those plaques should translate to a long-term benefit for patients.

Biogen has a plan to address each problem, Vounatsos said, but it will take time and patience.

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“Society is adjusting to this big news,” Vounatsos said. “And we’ve seen some of the extreme reactions — that I will not comment on. We as Biogen remain focused on the patients, the customers, making progress,” and getting more patients on Aduhelm by the end of the year.

Medicare is working through a monthslong process to determine how to cover the drug, which carries a list price of $56,000 a year. The majority of sites that might administer Aduhelm are waiting on Medicare’s decision before prescribing it, Biogen said.

Alisha Alaimo, president of Biogen’s commercial operations in the U.S., said “steady progress” is being made with Aduhelm’s commercial launch. But like Vounatsos, she outlined multiple issues that are causing the treatment’s uptake to be slower than the company anticipated.

Some physicians are reluctant to administer Aduhelm to patients until the data from its clinical trials are published in a peer-reviewed journal, she said. Biogen has submitted those papers and they are being reviewed, Vounatsos said, but he declined to offer a publication timeline.

Alaimo also said that some hospitals have reviewed Aduhelm and cleared its use but are still not administering the drug to patients because “operational issues” are delaying infusions.

Meanwhile, members of Congress have demanded information from both Biogen and the FDA about how Aduhelm was approved, citing STAT’s reporting that the company had an off-the-books meeting with a top agency official. The Department of Health and Human Services’ Office of Inspector General is conducting a separate investigation into the FDA’s use of a fast-track pathway to approve Aduhelm.

Source: STAT