The FDA notified Sarepta that “they are persevering with their evaluation and internal discussions related to our pending NDA for eteplirsen and will now not have the ability to complete their work by the Prescription Drug person price Act (PDUFA) purpose date of may additionally 26, 2016,” Sarepta said, in a announcement. “The FDA has communicated that they’ll keep to paintings past the PDUFA purposedate and attempt to complete their work in as well timed a way as feasible.”
In a statement, the FDA said:
“As cited inside the organisation‘s assertion, the FDA contacted Sarepta Therapeutics to let themunderstand we’re continuing necessary paintings on their New Drug software for eteplirsen and couldno longer take action via the purpose date. We can not comment further at the drug review, howeveryou can contact the business enterprise for extra information. The FDA is prohibited by way of lawfrom commenting on pending packages due to the fact such statistics is taken into consideration privateand proprietary to the applicant.”
Eteplirsen is a drug designed by means of Sarepta to treat Duchenne Muscular Dystrophy.