Roche Pauses Global Shipments of Elevidys Gene Therapy

Roche Holding AG temporarily halted shipments of its muscular disorder gene therapy, Elevidys, outside the U.S., mirroring its U.S. partner Sarepta Therapeutics. The pause affects orders relying on FDA approval and applies universally to Duchenne muscular dystrophy patients, showcasing a careful regulatory approach.

Roche Holding AG has announced a temporary suspension of its muscular disorder gene therapy, Elevidys, shipments to countries outside the United States. This decision follows a similar action by its U.S. partner, Sarepta Therapeutics, highlighting a regulatory cautionary stance.

The suspension, effective from Tuesday, impacts new Elevidys orders in countries that refer to the U.S. Food and Drug Administration (FDA) for local approval. Roche confirmed that this halt is voluntary, temporary, and extends to all Duchenne muscular dystrophy patients, irrespective of their ambulatory ability.

Roche acquired the commercial rights for Elevidys outside the U.S. from Sarepta Therapeutics in 2019. The development marks a significant moment for global neuromuscular therapeutic strategies, initially reported by Bloomberg News.