FDA Approves New Alzheimer’s Drug, First In Almost 20 Years

Yesterday, the U.S. Food and Drug Administration approved the first new Alzheimer’s disease drug in about 20 years. ‘Aduhelm’ was approved for treatment of early phases of the disease despite a committee’s decision last year that there was not enough evidence to support the effectiveness of the treatment. The drug was developed for patients with mild cognitive impairment, not severe dementia and intended to slow progression of Alzheimer’s disease not just ease its symptoms.

The FDA approved the drug using it’s accelerated approval program which allows for early approval of a drug for a serious or life-threatening illness even though more studies into it’s benefits may be needed. Under the accelerated approval, the drug will still be studied and with the program, companies are required to conduct ‘post-approval studies’ known as phase 4 confirmatory trials to verify the benefits of the treatment. The FDA has not approved a novel therapy for Alzheimer’s disease since 2003.