FDA conditionally approves controversial Alzheimer’s drug

The drug, a monoclonal antibody, is given monthly via injection to patients who suffer from early stages of the disease.

The U.S.’s pharma regulator, the Food and Drug Administration (FDA), made a much anticipated ruling on Monday, in conditionally approving the use of an Alzheimer’s drug, called aducanumab, the first such approval since 2003 . The drug, which goes by the brand name Aduhelm, has been granted ‘accelerated approval’ , meaning it will need to verify expected clinical benefits in a new trial. The drug’s approval had become controversial, with growing pressure from those impacted by the debilitating degenerative brain disease on one hand and opposition from many in the scientific community who were not convinced that the drug had demonstrated efficacy in trials, on the other. The FDA’s conditional approval on Monday took account of this. On Monday, Patrizia Cavazzoni, director of the FDA’s Centre for Drug Evaluation and Research, wrote on the organistion’s website that “the data included in the applicant’s submission were highly complex and left residual uncertainties regarding clinical benefit.”