A unanimous backing last Friday of Biogen's Alzheimer’s drug by the US health regulator’s advisers strengthened the case for a traditional approval with no major new safety warnings.
Reuters reports that the US Food and Drug Administration’s advisory panel unanimously agreed that a late-stage trial of the drug Leqembi, developed with partner Eisai, verified the benefit of treatment for those at an early stage of the disease.
The vote clears the way for a traditional approval by the agency, months after it gained an accelerated approval in January.
The advisers discussed the risk of using Leqembi in certain patients, like those taking drugs that prevent blood clots and those with a rare condition called cerebral amyloid angiopathy.
The condition causes the protein amyloid, that Leqembi targets, to build up in the walls of arteries in the brain and can cause bleeding.
But the advisers said that those concerns could be managed, and were balanced against the benefits provided by the drug.
"It seems unlikely that the updated FDA label will include additional contra-indications," said one observer, referring to the written information that accompanies an approved drug.
Traditional approval from the FDA is expected by 6 July.
Eisai’s confirmatory trial showed the drug slowed cognitive decline by 27% in early Alzheimer’s patients.
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