PTC Therapeutics (NASDAQ:PTCT) mentioned it has submitted a briefing doc to assist renewal of its conditional approval for Translarna in Europe and plans to fulfill with the FDA in Q1 2024 to debate the potential submitting of a market software for US approval.
The biotech firm mentioned it submitted the briefing doc to EU regulators as a part of a reexamination of a damaging opinion on the drug by the Committee for Medicinal Merchandise for Human Use, or CHMP. The reexamination is anticipated to final till late January, after which CHMP will present an opinion. The opinion would then be despatched inside 67 days for adoption by the European Fee.
PTC additionally met with the FDA, which prompt it request a gathering to debate particular knowledge and data that might be used to assist a New Drug Utility for the product. PTC mentioned it expects the FDA assembly to happen in Q1 2024.
Translarna, also called ataluren, has conditional approval within the EU for the therapy of a sure sort of Duchenne muscular dystrophy. The product is just not but accredited within the US.
PTC Therapeutics (NASDAQ:PTCT) mentioned it has submitted a briefing doc to assist renewal of its conditional approval for Translarna in Europe and plans to fulfill with the FDA in Q1 2024 to debate the potential submitting of a market software for US approval.
The biotech firm mentioned it submitted the briefing doc to EU regulators as a part of a reexamination of a damaging opinion on the drug by the Committee for Medicinal Merchandise for Human Use, or CHMP. The reexamination is anticipated to final till late January, after which CHMP will present an opinion. The opinion would then be despatched inside 67 days for adoption by the European Fee.
PTC additionally met with the FDA, which prompt it request a gathering to debate particular knowledge and data that might be used to assist a New Drug Utility for the product. PTC mentioned it expects the FDA assembly to happen in Q1 2024.
Translarna, also called ataluren, has conditional approval within the EU for the therapy of a sure sort of Duchenne muscular dystrophy. The product is just not but accredited within the US.