On Thursday shares of Sarepta Therapeutics (SRPT) closed up 15% for the day as the company stated that the FDA had set a new FDA independent panel review date. The original review date for Sarepta’s drug Eteplirsen was set to happen on January 20th. The problem was that a forecast of weather, that week forced the agency to cancel the meeting.
Now the FDA panel meeting is set to take place on April 25, where the independent panel will determine if Eteplirsen has sufficient efficacy and safety to warrant approval. This FDA panel that is reviewing the drug on this date, is not for final approval. This body is an independent panel made up of clinicians and doctors who will either recommend or not recommend the drug for approval.
The final decision comes down by the FDA itself on May 26, this year. The FDA doesn’t have to listen to the panel though, but they normally take their recommendation into high consideration. Despite this, it is not a guarantee that the FDA will approve Eteplirsen therefore investors should hedge themselves if possible, remain cautious.
The comments released one day after Kyndrisa was dismissed by the FDA, displayed a negative review by the FDA for Eteplirsen being hesitant about the efficacy of the drug. Kyndrisa was another Duchenne Muscular Dystrophy — DMD — drug that targeted another subset of patients. There is only one advantage that Sarepta has now in terms of approval.
There are no FDA approved drugs for DMD, and it is a huge unmet medical need. The FDA has been receiving pressure to approve a drug to help these patients. Drugs by rivals have already been rejected, therefore there is a small chance that the FDA may decide to approve the drug. Although this will only happen if the FDA feels there is enough evidence that Eteplirsen shows clinical benefit, and that is the huge hurdle ahead.
