FDA Approves First New Alzheimer's Drug In Two Decades

Issue 74

The first drug showing promise to slow Alzheimer’s disease was approved by U.S. health regulators after years of research and billions of dollars in investment.

The United States Food and Drug Administration said it approved the Biogen created drug, which has the molecular name aducanumab and will be sold as Aduhelm, based on evidence it reduces a sticky substance in the brain called amyloid that is associated with Alzheimer’s.

The drug’s sale offers hope to millions of people dealing with Alzheimer’s and their caregivers, given the lack of good options for treatment. Yet aducanumab’s impact may be limited. Doctors who say they will prescribe the drug caution it won’t help all patients, particularly those with more advanced disease. Some patients eligible for treatment may face $10,000 or more in annual out-of-pocket costs according to health insurer Cigna totally covered and uncovered costs would reach about $56,000 a year per patient.

Some doctors, however, say the evidence supporting the drug’s efficacy is limited and recommended against its approval. About six million people suffer from Alzheimer’s in the United States about 1.4 million would be eligible for treatment. The FDA last approved a new Alzheimer’s drug in 2003.

Source: Bloomberg