PTC Therapeutics Inc. has announced that their drug SEPHIENCE™ (sepiapterin) has received marketing authorization from the European Commission. This approval allows PTC Therapeutics to bring their treatment to children and adults with phenylketonuria (PKU) across Europe. The approval follows significant efficacy and safety results from the Phase 3 APHENITY trial and its long-term extension study. Additionally, regulatory review processes are ongoing in several other countries, including Japan and Brazil, reflecting the global reach and potential impact of SEPHIENCE in addressing the unmet needs of the PKU community.
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