Government health officials have approved the first new drug for Alzheimer’s disease in nearly 20 years. The Food and Drug Administration said it granted approval to the drug from Biogen based on results that seemed “reasonably likely” to benefit Alzheimer’s patients.
It’s the only drug that U.S. regulators have said can likely treat the underlying disease, rather than manage symptoms like anxiety and insomnia.
This is in spite of independent advisers feeling that it hasn’t been shown to help slow the brain-destroying disease.
The decision is certain to have disagreements among physicians, medical researchers and even patient groups.
The new drug, which Biogen developed with Japan’s Eisai Co., did not reverse mental decline, only slowing it in one study. The medication, aducanumab, will be marketed as Aduhelm and is to be given every four weeks.
Dr. Caleb Alexander, an FDA adviser who recommended against the drug’s approval, said he was “surprised and disappointed” by the decision.
“The FDA gets the respect that it does because it has regulatory standards that are based on firm evidence. In this case, I think they gave the product a pass,” said Alexander, a researcher at Johns Hopkins University.
Since the FDA’s approval researchers and pharma watchers have called the agency’s decision “disgraceful,” “a grave error” and a “dangerous precedent” that will end up “eroding confidence in the agency as a whole.”
The FDA’s top drug regulator acknowledged in a statement that “residual uncertainties” surround the drug, but said Aduhelm’s ability to reduce harmful clumps of plaque in the brain “is expected” to help slow dementia.
The FDA is requiring the drugmaker to conduct a follow-up study to confirm benefits for patients. If the study fails to show effectiveness, the FDA could pull the drug from the market.
Nearly 6 million people in the U.S. have Alzheimer’s.
Aducanumab (pronounced “addyoo- CAN-yoo-mab”) helps clear a protein linked to Alzheimer’s, called betaamyloid, from the brain.
