According to the Swiss pharmaceutical company, the halt, which goes into effect on 22nd July 2025 covers new Elevidys orders in non-US nations that rely on local approval from the Food and Drug Administration.
After consulting with local regulatory bodies, Roche stated that it will keep shipping the therapy to ambulatory patients in other nations where it has been approved. – Read More: Sarepta Therapeutics Announces Pause of ELEVIDYS Shipments in the USA –
Japan, Brazil, Israel, the United Arab Emirates, Qatar, and Kuwait are among the nations that have approved Elevidys.
According to Roche’s emailed statement, the suspension is temporary and optional for all patients with Duchenne muscular dystrophy, regardless of their walking ability.
Late on Monday, Sarepta announced that it would abide by the FDA’s request to stop all Elevidys shipments within the US.
Following the deaths of two adolescent boys who received Elevidys this year, Sarepta announced on Friday that another patient who had received its experimental gene therapy had passed away following acute liver failure. This prompted the FDA to request the treatment.
Roche stated that it is in communication with health authorities worldwide to ascertain the next possible steps and is attempting to ascertain the reason behind the FDA’s request.
In 2019, Roche purchased the non-US commercial rights to Sarepta’s Elevidys.
The development was initially reported by Bloomberg News.
Learn More: Frequently Asked Questions About Elevidys
