FDA approves weekly Alzheimer’s drug

The FDA has approved Biogen’s Alzheimer’s drug Leqembi for injection to treat individuals with mild cognitive impairment or mild dementia. 

The drug can now be administered as a once-weekly injection using an autoinjector device, compared to the previous method of IV infusions every two weeks, according to an Aug. 29 news release from the drugmaker. 

The approval is based on phase 3 clinical trial data, which showed the injection worked as well as the IV solution in slowing cognitive decline; it also had fewer side effects. The study found that fewer than 1% of patients had whole body reactions to the treatment, compared to around 26% with the IV treatment. 

Leqembi is the only Alzheimer’s treatment that targets amyloid plaque and smaller toxin particles called protofibrils, which can lead to buildup of another harmful protein, the release said. 

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