Time.news – US drug agency announced change of recommendations for use of new Alzheimer’s drug approved just a month ago, limiting its use to people with moderate cases of the disease. Dubbed ‘Aduhelm’ and manufactured by pharmaceutical company Biogen, it was the first Alzheimer’s treatment approved since 2003, but its approval through an accelerated process shook the scientific community.
With an uncommon practice, the American Food and Drug Administration (FDA) went against the advice of a committee of experts, which had determined that the treatment had not sufficiently demonstrated its effectiveness. Committee members resigned in protest after the drug was approved.
“Since the agency approved Aduhelm, doctors and others have reported much confusion among the population destined for this treatment.“An FDA spokesperson told AFP.” Upon hearing these concerns, the FDA determined that clarification could be made.
The new recommendations now include the clarification that the treatment “it should be initiated in patients with moderate cognitive impairment or in a moderate dementia stage of the disease“Since the disease is characterized by progressive loss of memory and some cognitive functions, for patients who are receiving treatment but gradually slip into a more advanced stage of the disease, doctors must” evaluate the potential benefit “of continuing the treatment. case-by-case treatment, established the FDA.
The drug uses monoclonal antibodies, called aducanumab, and should be given every four weeks by intravenous injection. Nearly 6 million Americans are living with Alzheimer’s, which is the sixth leading cause of death in the United States. But Treatment studies have suffered one setback after another in recent years, and there is still no cure. This drug has been seen as an opportunity for hope by affected patients and their relatives. Also because the treatments that have been approved so far only fight the symptoms of Alzheimer’s.
Biogen’s treatment targets the mechanism of the disease itself. It tries to destroy the plaques formed by certain proteins, known as “amyloids”, which compress neurons in the brains of patients. This is one of the main avenues explored by research on this disease in recent years.