The U.S. Food and Drug Administration (FDA) has placed a clinical hold on SRP-5051 (vesleteplirsen), Sarepta Therapeutics' (NASDAQ:SRPT) lead candidate to treat patients with Duchenne muscular dystrophy.
The regulatory decision follows a serious adverse event of hypomagnesemia in the Part B of MOMENTUM Study 5051-201, investigated SRP-5051 (vesleteplirsen) for Duchenne muscular dystrophy in the Phase 2 clinical trial.
Sarepta said that the FDA has requested details on all cases of hypomagnesemia, including a small number of non-serious grade 2 cases, and to assess the adequacy of the risk mitigation and safety monitoring plan.
Rodino-Klapac, Executive vice president and chief scientific officer, commented : "Patient safety is always our top priority. The hypomagnesemia was identified through lab tests conducted as part of the monitoring outlined in the protocol of the MOMENTUM study and is similar to previously observed cases of hypomagnesemia in clinical trials of SRP-5051. The hypomagnesemia was transient and patients' magnesium levels returned to normal following additional supplementation."
The company is planning respond to the FDA with requested information and proposed changes to the monitoring plan.
Sarepta Therapeutics shares are trading down 8 percent at $66.50 in the after hours.
