FDA CONDITIONALLY APPROVES ALZHEIMERS DRUG

FDA CONDITIONALLY APPROVES ALZHEIMERS DRUG

Subject: Science & tech

Context: 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.

Concept:

• 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.

About the Drug

• Aducanumab is based on the amyloid hypothesis of the disease — that plaques made of beta amyloid peptide (a type of protein) form in the patients brain leading to cognitive decline and problems with thinking.
• The drug supposedly binds to beta amyloid molecules and removes them. The drug, a monoclonal antibody, is given monthly via injection to patients who suffer from early stages of Alzheimer’s.