Switzerland-based healthcare company Roche announced on Monday that it has received its first FDA approval for the company's paroxysmal nocturnal haemoglobinuria (PNH) treatment drug, PIASKY (crovalimab).
The FDA accepted a biologics license application for crovalimab in September 2023 and subsequently approved it in June 2024 for treating PNH in adults and adolescents aged 13 years and older.
The approval has increased competition between the company and the current market leader, AstraZeneca. Other pharma companies are also geared up to introduce their respective lead assets.
PiaSky is also undergoing review by other regulatory authorities, including those in Europe and Taiwan.
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