Sarepta Refuses FDA Request to Stop Shipping Muscular Dystrophy Drug Elevidys

Sarepta Therapeutics, a biopharmaceutical company, has refused the FDA's request to stop shipping its muscular dystrophy drug, Elevidys. The FDA had asked Sarepta to halt all shipments of the therapy after three patients died from liver failure after taking Elevidys or a similar treatment. Sarepta has stated that it will continue to make Elevidys available to patients, citing the potential benefits of the drug and the lack of alternative treatment options for those with muscular dystrophy. The company has also emphasized that the deaths are still under investigation, and there is no clear link between the drug and the reported liver failures. The decision by Sarepta to refuse the FDA's request highlights the ongoing debate surrounding the balance between patient access to experimental drugs and the need for rigorous safety protocols. The situation underscores the complex challenges faced by regulatory agencies and pharmaceutical companies in ensuring the safety and efficacy of new therapies.