Denali Therapeutics Announces U.S. FDA Approval of AVLAYAH™ (tividenofusp alfa-eknm) for Treatment of Hunter Syndrome (MPS II)
Denali Therapeutics announced that the U.S. FDA has granted accelerated approval for AVLAYAH™ (tividenofusp alfa-eknm), a novel enzyme replacement therapy designed to cross the blood-brain barrier to treat neurological symptoms of Hunter syndrome (MPS II). This marks the first FDA-approved treatment targeting the brain manifestations of this rare g…