The Food and Drug Administration (FDA) approved an Alzheimer’s drug today called Aducanumab. It is the first time the FDA approved a new therapy for the disease since 2003.

However, an independent advisory panel has asked the FDA to reject the drug stating the treatment hadn’t been shown to help slow the progression of the disease.

Aducanumab is the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms such as anxiety and insomnia.

It will be manufactured by Biogen and it will be sold under the name Aduhelm.

Director of the FDA’s Center for Drug Evaluation and Research Dr. Patrizia Cavazzoni explained this morning the drug had been approved through the FDA’s accelerated approval pathway. That is an approach which allows the FDA to approve drugs for serious or life-threatening illnesses when the drug has been shown to show improvement on a surrogate endpoint that is considered to be reasonably likely to predict clinical benefit. Drugs approved through the FDA’s accelerated pathway must continue to study the drug to confirm its clinical benefits. The FDA is requiring the drug maker to conduct a follow-up study to confirm the drug’s benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market.

Biogen officials say the drug is given as an infusion every four weeks at a cost of $4,312 per infusion, based on the average weight of a patient with mild cognitive impairment or mild dementia.

(Picture courtesy of Alzheimer’s Foundation of America)