Biogen’s Alzheimer’s drug Aduhelm was approved for sale by the FDA in June. But whether or not it actually works is another question entirely.
Thanks to a new accelerated trial timeline announced by the company on Thursday, the answer to that all-important question will come sooner than expected.
Red Light, Green Light
When the FDA gave Aduhelm approval in June, it came as a bit of a surprise— mostly because the agency’s expert panel had rejected the drug the previous November. It also came with a catch. Aduhelm was placed on an accelerated approval process, a pathway often reserved for potentially life-changing drugs that show signs of positive effects even without demonstrated clinical benefits.
The accelerated process requires pharma companies to perform confirmatory studies. The Stage 4 trial was expected to take 9 years for Biogen to complete. But on Thursday, the company announced plans to finish it in just 4 years, with an end date in August 2026. The news may help Biogen steer out of a months-long skid of business disappointments since Aduhelm first gained FDA approval this Summer:
- In its third-quarter earnings report posted in October, Biogen said it only recorded $300,000 in Aduhelm sales—a far cry from the $12 million figure some analysts projected.
- Only 120 US sites offered the drug, short of the 900 Biogen expected, as commercial insurers hesitate to cover the $56,000-per-year drug.
Biogen’s stock, meanwhile, has tumbled nearly 6% in the past twelve months, even as the S&P 500 has seen a 25% bump in 2021.
Tough Pill To Swallow: That’s not all the recent bad news for Biogen. Following the disappointing earnings report, the company’s longtime R&D lead and science chief unexpectedly announced his retirement—sparking another stock dip. And earlier this month, reports surfaced that Biogen plans to lay off over 10% of its workforce, nearly 1,000 employees, in early 2022.