FDA slaps CRL on PTC Therapeutics’ vatiquinone NDA
PTC Therapeutics (Nasdaq: PTCT) yesterday revealed that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) related to the New Drug Application (NDA) for vatiquinone for the treatment of children and adults living with Friedreich's ataxia.
"We are of course disappointed by the FDA's decision to not approve vatiquinone," said Dr Matthew Klein, chief executive of PTC Therapeutics, adding: "We believe the data collected to date demonstrate that vatiquinone could provide a safe and effective therapy for both children and adults living with Friedreich's ataxia. We plan to meet with the FDA to discuss potential steps to address the issues raised in the CRL."
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