Cowley Leongini Quoted on Sarepta’s Halt of Duchenne Gene Therapy Sales Amid FDA Scrutiny
GenomeWeb
Partner Emily Cowley Leongini was quoted on Sarepta Therapeutics’ decision to pause sales of its Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec) following a request from the US Food and Drug Administration (FDA).
The FDA’s request followed news of a patient death tied to an experimental gene therapy treatment that uses the same adeno-associated virus serotype, AAVrh74, as Elevidys.
Though this is the first time the FDA has taken this type of action against a gene therapy, it is not the first time the agency has requested a drug manufacturer to stop distributing a product.
Emily said that this is a “pretty novel situation,” and that “this does not happen a lot.”
To resume distribution, Sarepta will have to convince the FDA that Elevidys is sufficiently safe, which could involve changing its label or establishing whether there’s a need to limit the population that’s eligible for the product.
“There’s going to be a back-and-forth with the FDA,” Emily said. “That’s typically not a quick process, particularly not when there have been deaths involved.”
Read the full article here. (Subscription required)
Contacts
- Related Industries
- Related Practices