FDA approves first new Alzheimer's disease drug in nearly 20 years
For the first time in nearly 20 years, the US Food and Drug Administration has approved a drug for the treatment of early Alzheimer’s Disease -- against the advice of an FDA advisory committee that said last year there wasn’t enough evidence the treatment is effective.
Aducanumab, which will be sold under the brand name Aduhlem, was developed for patients with mild cognitive impairment, not severe dementia, and is intended to slow the progression of Alzheimer's disease -- not just ease symptoms.
The FDA has not approved a novel therapy for Alzheimer's disease since 2003.
The drug was approved under the FDA’s "accelerated approval" program, which allows for the faster approval of a drug for a serious or life-threatening illness, even though more study into the drug's benefits may be needed.
With this program, drug companies are required to conduct "post-approval studies," known as Phase 4 confirmatory trials, to verify that treatments have clinical benefit. If the confirmatory trial does not verify the drug's benefit, the FDA can remove it from the market.
"There has been considerable public debate on whether Aduhelm should be approved. As is often the case when it comes to interpreting scientific data, the expert community has offered differing perspectives," Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in Monday's announcement.
But ultimately the FDA "concluded that the benefits of Aduhelm for patients with Alzheimer's disease outweighed the risks of the therapy."
In March 2019, Phase 3 clinical trials of aducanumab were discontinued because a futility analysis found the trials were unlikely to meet their primary goals at completion. But, several months later, the drug’s developer, Biogen, announced that a new analysis, which included more patients, showed 22% less clinical decline in patient’s cognitive health at about 18 months -- meaning the progression of the patient’s disease slowed -- compared with those who received a placebo.