Washington: US health officials on Monday approved the first new drug for Alzheimer's disease in nearly 20 years, disregarding warnings from independent advisers that the treatment hasn't helped slow down the brain-destroying disease.
The drug, which goes by the brand name Aduhelm, is a monthly intravenous infusion intended to slow cognitive decline in people in the early stages of the disease, with mild memory and thinking problems. It is the first approved treatment to attack the disease process of Alzheimer’s instead of just addressing dementia symptoms.
The decision, which could impact millions of older Americans and their families, is certain to spark disagreements among physicians, medical researchers and patient groups. It also has far-reaching implications for the standards used to evaluate experimental therapies, including those that show only incremental benefits.
The FDA wants the manufacturer 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.
Pharma company Biogen did not immediately disclose the price, though analysts have estimated the drug could cost between $30,000 and $50,000 for a year's worth of treatment
Nearly 6 million people in the US and many more worldwide have Alzheimer's, which 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 of more Baby Boomers progress further into their 60s and 70s.
Aducanumab (pronounced "add-yoo-CAN-yoo-mab") aims to help clear harmful clumps of a protein called beta-amyloid from the brain. Other experimental drugs have done that before, but they made no difference in patients' ability to think, take care of themselves or live independently.
The pharmaceutical industry's drug pipeline has been littered for years with failed Alzheimer's treatments, representing billions in research costs.