Sarepta Therapeutics (SRPT) said Friday that recruitment and dosing in some trials of Elevidys to treat Duchenne muscular dystrophy have been temporarily suspended after EU authorities requested that the independent data monitoring committee meet to review an adverse event.
The company said the panel met on Thursday and concluded that the "overall benefit-risk profile remains favorable to continue dosing in the paused clinical trials without changes to the study protocols."
Sarepta said that it and and its partner Roche will respond to the temporary halt within a week, as requested by EU regulators.
"The subsequent decision for lifting the temporary halt will follow the EU regulatory process," Sarepta said.
Sarepta said on March 18 that a young patient in the US died of acute liver failure after receiving Elevidys. Although acute liver injury is a known potential side effect of the therapy, the company said liver failure resulting in death had not been previously reported in over 800 treated patients.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.