“There are not any safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied”, the corporate added.
Aduhelm is that the first Alzheimer's medication approved by the FDA in nearly 20 years. The US drug regulator’s approval of Aduhelm last month drew sharp criticism over the effectiveness of the drug. Three experts even resigned from an FDA committee over the agency’s decision to approve a drugs that only slowed the mental decline in one study that was marred by hard-to-interpret results.
“Based on our ongoing conversations with prescribing physicians, FDA and patient advocates, we submitted this label update with the goal to further clarify the patient population that was studied across the three Aduhelm clinical trials that supported approval”, Alfred Sandrock, Jr., head of research and development at Biogen, said during a statement.
Alzheimer’s disease is an irreversible, progressive encephalopathy that slowly destroys memory and thinking skills, and eventually, the power to hold out simple tasks. Before Thursday's announcement, the FDA approval wasn't limited to early patients or those with mild cognitive impairment. But anyone with Alzheimer's, a minimum of theoretically, could get the drug prescribed.
The drug can cause serious side effects including Amyloid Related Imaging Abnormalities, or “ARIA”, a side effect that doesn't usually cause any symptoms but are often serious. ARIA is most ordinarily seen as temporary swelling in areas of the brain that sometimes resolves over time and a few people can also have small spots of bleeding in or on the surface of the brain with the swelling, said Biogen.
