Drugmaker ends study and sales of once-promising drug
Cambridge-based pharmaceutical company, Biogen, announced on Wednesday that it will cease development of its Alzheimer’s treatment, Aduhelm. This comes after the drug’s initial launch a couple of years ago faced setbacks and failed to meet expectations. The decision includes terminating the study necessary for full approval from the Food and Drug Administration (FDA) and halting sales of Aduhelm.
Continued availability and focus on other treatments
Patients currently taking Aduhelm through the commercial market will be able to continue their doses until November. It has been estimated that approximately 2,500 individuals worldwide are currently receiving Aduhelm. Biogen has stated that it will now shift its focus to other treatments for Alzheimer’s, a devastating and debilitating disease. The company is also collaborating with Japanese drugmaker Eisai to sell another FDA-approved Alzheimer’s treatment called Leqembi.
Leqembi shows promise in slowing cognitive decline
Leqembi has been hailed as the first medication that has convincingly demonstrated the ability to slow the cognitive decline caused by Alzheimer’s disease, albeit modestly. Regulators have approved it for patients with mild dementia and other symptoms associated with early-stage Alzheimer’s.
Aduhelm’s rise and fall
Aduhelm, introduced as the first new Alzheimer’s drug in nearly two decades, received accelerated approval from the FDA in 2021. However, full approval was contingent on an additional study. With a price tag of $56,000 per year, industry analysts predicted Aduhelm to be a blockbuster drug with the potential to generate billions for Biogen. However, due to weak evidence of its efficacy in slowing Alzheimer’s progression, many doctors were reluctant to prescribe the intravenous drug. Insurers also imposed restrictions on coverage, and the Medicare program, which covers most elderly Alzheimer’s patients, enforced strict limits on access.
Ultimately, Aduhelm fell short of expectations, generating only millions in quarterly sales for Biogen instead of the anticipated billions. In 2022, the company announced a significant reduction in Aduhelm marketing efforts. Last year, Biogen unsuccessfully sought outside financing or partnerships to support Aduhelm. The decision to discontinue the drug came after a thorough review of the company’s research and development program, which considered the time, investment, and likely advancements required for the additional study before full approval.
Financial impact and market response
Biogen anticipates booking a charge of approximately $60 million in the fourth quarter to account for the shutdown of the Aduhelm program. Despite this setback, shares of Biogen Inc. rose over $4 to $251.72 on Wednesday morning, while the broader market, as represented by the Standard & Poor’s 500 index, experienced a slight decline.