Waylivra granted Category 1 classification in Brazil
Shares of PTC Therapeutics (Nasdaq: PTCT) were up 6.9% to $42.58 by close of trading on Monday, ahead of formally announcing that Waylivra (volanesorsen) has successfully received Category 1 classification from Câmara de Regulação do Mercado de Medicamentos - CMED (Drug Market Regulation Chamber) in Brazil.
Waylivra is the only treatment for familial chylomicronemia syndrome (FCS) in Brazil, following its approval by the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), in August 2021.
Category 1 classification is given to innovative treatments that provide greater efficacy than current standards of care, and it allows for pricing in line with international markets.
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