Biogen’s Alzheimer’s Drug To Enter New Trial Stage Next Year

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.