Despite concerns from independent advisers that the much-debated medication has not been shown to help slow the brain-destroying disease, US government health officials approved the first new medicine for Alzheimer’s disease in nearly 20 years.
It is the only drug that US regulators have said can likely treat the underlying disease.
The medicine produced by Biogen for individuals with Alzheimer’s disease has been approved by the Food and Drug Administration.
It’s the only medicine that US regulators say has a good chance of treating the underlying ailment rather than just managing symptoms like anxiety and insomnia.
Physicians, medical experts, and patient groups are bound to dispute over the decision, which could affect millions of people and their families.
The new drug, which Biogen developed with Japan’s Eisai Co, did not reverse mental decline, only slowing it in one study.
The drug, Aducanumab, is given as an infusion every four weeks.
The FDA is requiring the drugmaker to conduct a follow-up study to confirm the drug’s benefits for patients.
If the study fails to show effectiveness, the FDA could pull the drug from the market, though the agency rarely does so.
Biogen did not immediately disclose the price, though analysts have estimated the drug could cost between 30,000 and 50,000 US dollars for a year’s worth of treatment.
A preliminary analysis by one group found that the drug would need to be priced 2,500 to 8,300 US dollars per year to be a good value based on the “small overall health gains” suggested by company studies.
Alzheimer’s gradually attacks areas of the brain needed for memory, reasoning, communication and basic daily tasks.
In the final stages of the disease, those afflicted lose the ability to swallow.
The global burden of the disease, the most common cause of dementia, is only expected to grow as millions more baby boomers progress further into their 60s and 70s.
Aducanumab aims to help clear harmful clumps of a protein called beta-amyloid from the brain.