PTC Therapeutics announced on September 11, 2025, the commercial launch of SUFIANCE (sepiapterin) for the treatment of phenylketonuria (PKU). This launch follows the recent approvals of Sephience (the brand name for sepiapterin in Europe) by both the U.S. Food and Drug Administration (FDA) and the European Commission.
The introduction of SUFIANCE reinforces PTC Therapeutics' position in rare disease innovation, providing a new oral therapy for adult and pediatric PKU patients. The drug is positioned to become a new standard of care due to its broad labeling and compelling clinical data.
This commercial launch is a critical step for PTC Therapeutics, as it begins to generate revenue from a product expected to be a foundational driver of future growth. The company's experienced commercial teams are prepared to bring this therapy to patients in both the United States and Europe.
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