Denali Wins FDA Approval for Hunter Syndrome Drug (1)

Denali Therapeutics Inc. won US approval for its treatment for Hunter syndrome, marking a victory for the biotech company after other rare disease drugmakers have faced setbacks with regulators.

The drug, which received accelerated approval from the US Food and Drug Administration, will be sold under the name Avlayah. It’s an IV infusion given once weekly and greenlit to treat neurologic complications from the disorder.

The agency was expected to clear the company’s treatment for Hunter syndrome by April 5. On Wednesday morning, the FDA posted on its website that it had backed the drug, but then removed the ...