Drugmaker Biogen has until 2030 to complete a study confirming whether its new drug Aduhelm truly slows the brain-destroying disease. That's under the terms of the Food and Drug Administration's conditional approval of the drug, a decision that has been praised by patients as overdue and condemned by the agency's own outside experts.
But both camps agree: 2030 is far too long to wait for answers on the $56,000-a-year drug.
"We think nine years is unacceptable and our expectation is that it will happen in a much shorter time frame," said Maria Carrillo of the Alzheimer’s Association, an advocacy group that pushed for approval but now wants the FDA to set a quicker deadline.
Other experts warn that the 2030 timeline could slip if patients balk at enrolling in a new study for a drug that’s already available. And the focus on Aduhelm — the first new Alzheimer’s drug in 18 years — could steer volunteers away from testing of other promising treatments.
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