Posted by Michael Wonder on 17 Aug 2019
As Sarepta awaits approval of new Duchenne drug, big questions hang over therapy already on market
15 August 2019 - As Sarepta Therapeutics waits for the FDA to announce an approval decision on a new drug to treat Duchenne muscular dystrophy, the biotech is years behind schedule on a requirement to confirm the muscle-function benefit of its first and top-selling medicine Exondys 51.
The FDA has until Monday to decide if Sarepta can market a second drug called Vyondys 53 to treat patients, mostly young boys, with the inherited and fatal muscle-wasting disease.
