STAT+: Sarepta Therapeutics\u2019 Duchenne therapy faces \u2018arduous\u2019 path back to market, senior FDA official says
\n \t
\n
<\/BR>
\n
\n \t
\n
<\/BR><\/p>\n
Sarepta Therapeutics, the maker of a gene therapy for Duchenne muscular dystrophy that is being temporarily shelved because of safety concerns<\/a>, faces an \u201carduous and treacherous path\u201d to try to get it back onto the market, a senior Food and Drug Administration official told STAT, suggesting the treatment\u2019s license could be revoked.\u00a0<\/p>\n The official, who spoke to STAT on condition of anonymity, did not rule out the possibility that the therapy, Elevidys, could eventually be brought back on the market. But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries \u2014 which have been tied to the deaths of two patients<\/a> \u2014\u00a0the official added.<\/p>\n \u201cHow do you show something is safe when it\u2019s already proven to be not safe?\u201d the official said.\u00a0<\/p>\n Continue to STAT+ to read the full story\u2026<\/a><\/p>\n<\/div>\n