Boston, MA 04/21/2014 (wallstreetpr) – Sarepta Therapeutics Inc (NASDAQ:SRPT) plans to start new trials on experimental drug after the U.S. Food and Drug Administration said that the data available could support approval.
The company is developing a drug called eteplirsen that is targeted for the treatment of Duchenne Muscle Dystrophy (DMD). The condition affects about one in every 3,600 newborn male babies. The disease hampers movement in the victims.
According to FDA, new data on safety and efficacy could support marketing application for the DMD drug.
Failed attempt
Sarepta Therapeutics Inc (NASDAQ:SRPT) failed late last year when it attempted to seek approval for its experimental drug based on previous trial data. However, the regulator declined to approve the treatment citing insufficient data. The regulator also cited new DMD data as well as the data from a failed experimental drug by Prosensa Holding NV (NASDAQ:RNA) for the treatment of DMD.
Prosensa is a biotech company that discovers and develops drugs for various treatments. The company presented data from the trial of its DMD experiment drisapersen but failed to secure approval as FDA observed that there was no significant data to support claims that the drug helped patients to walk.
Accelerated approval
Sarepta Therapeutics Inc (NASDAQ:SRPT) expects success in the latest trial for eteplirsen. The company plans to present marketing application for the drug by end of 2014 while taking advantage of the accelerated approval privilege granted to the experimental drug by FDA.
The FDA suggested accelerated approval pathway for the drug. The accelerated approval is granted to drugs that target the treatment of serious conditions whose medical needs are unmet. However, FDA grants accelerated approval on experimental drugs based on preliminary trial data.
The fact that FDA granted accelerated approval for eteplirsen goes a long way to show that new data on the drug could be important towards its approval as recommended.
Good news for investors, advocates
Patient advocates and investors have been lobbying to have FDA approve eteplirsen. The latest development comes as good news for the patient advocates and investors as Sarepta Therapeutics Inc (NASDAQ:SRPT) seems to edge closer to bringing to the market a drug with the potential of filling a medical gap and driving higher revenue to the company.
Shares of the company surged more than 75 percent in pre-market session on the news that the new study on eteplirsen will be launched and marketing application submitted by year-end. The announcement by Sarepta Therapeutics Inc (NASDAQ:SRPT) also helped the stock of Prosensa Holding NV that is also developing treatment for DMD to surge.
