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Pharmaceutical manufacturer Biogen reported On Wednesday, the new Alzheimer’s drug, Aduhelm, brought in $300,000 from July to September, well below the company’s targets and Wall Street expectations.
The sales figures Biogen announced in its third-quarter financial report, the drug’s first period of full availability, represented a rather slow start for a treatment that was promoted with a $56,000 annual price tag and expectations it could push Medicare’s budget. several years. Uptake has slowed significantly among insurers, physicians and families, amid concerns that the drug carries a significant risk of potentially serious side effects while supported by little evidence of its effectiveness.
“This is a huge disappointment,” said Brian Skorney, an analyst at Robert W. Baird & Company.
“People have been talking for a while about this being potentially the greatest drug ever,” he added. “There really is no drug that has had such a slow start that has been successful to this extent.”
Wall Street analysts had predicted that the drug would bring in at least $12 million in the third quarter, although expectations softened after the news organization. STAT reported last month He said more than 100 patients received treatment in the first few months. Biogen’s stock rose nearly 0.3 percent on Wednesday.
Biogen did not disclose how many patients were treated during the July-September period. Treatment within the first few weeks of launch in June brought in $1.6 million most in revenue from stockpiled inventory. Biogen said on Wednesday it expects Aduhelm to continue to generate minimal revenue for the rest of this year, a damaging blow to the company that relied on the drug to offset the drop in revenue from other products.
Biogen’s CEO, Michel Vounatsos, told analysts that the company “doesn’t panic” over the low sales figures and continues to “believe in Aduhelm’s long-term potential”. He attributed the slow sales to a lack of clarity on whether the drug would be paid for by insurers.
federal agency that administers Medicare said in July He said he’s embarking on a months-long review to determine whether the nationwide coverage of the drug will be standardized, a step that could limit which patients can take the drug. A draft decision is expected in January, with a final decision expected by April.
Many leading academic medical centers, including the Cleveland Clinic and Mount Sinai Health System in New York, decided not to give the drug to patients. Several regional Blue Cross Blue Shield health plans refused to cover it, and in August the Department of Veterans Affairs decided not to add the drug to existing drug formulas.
Despite conflicting clinical trial results, the Food and Drug Administration decided to approve Aduhelm, given as a monthly intravenous infusion, in June, and internal opposition among reviewers and advisors. In one study that showed a positive outcome, the high-dose drug slowed the decline by 0.39 on an 18-point scale. Typically mild but potentially serious side effects, such as brain swelling or bleeding, occurred in 40 percent of clinical trial participants.
The agency’s independent advisory panel and many outside scientists opposed the approval decision. Several members of the panel resigned in protest. The FDA itself later called for a federal investigation of the process that led to the approval.
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