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PTC Therapeutics' Waylivra Scores Approval In Brazil For Genetic Disorder

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  • The Brazilian Health Regulatory Agency has approved PTC Therapeutics Inc's (NASDAQ: PTCT) Waylivra (volanesorsen) as the first treatment for familial chylomicronemia syndrome (FCS).

  • The approval is based on the Phase 3 APPROACH study results and the APPROACH Open-Label Extension study and is supported by results from the Phase 3 COMPASS study.

  • Results from the Phase 3 APPROACH trial showed that the treatment reduced triglycerides by 94% compared to placebo. All patients in the trial maintained a low-fat diet.

  • Waylivra is a self-administered, subcutaneous injection that comes in a single-use, prefilled syringe.

  • Waylivra (volanesorsen), a product of Ionis Pharmaceuticals Inc's (NASDAQ: IONS) antisense technology, is conditionally approved in the E.U. for FCS.

  • FCS is a genetic disease caused by impaired function of the enzyme lipoprotein lipase and characterized by severe hypertriglyceridemia and risk of unpredictable and potentially fatal acute pancreatitis.

  • Related content: Benzinga's Full FDA Calendar.

  • Price Action: PTCT shares closed 3.48% higher at $39.53 on Monday.

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