- FDA tentative schedules Peripheral and Central Nervous Systems Drugs Advisory Committee meeting for September 28 to review the new drug application for ataluren.
- Ataluren, formerly known as PTC124, is a pharmaceutical drug for the treatment of Duchenne muscular dystrophy, cystic fibrosis, and potentially other genetic disorders involving prematurely truncated proteins. It was designed by PTC Therapeutics and is sold under the trade name Translarna in the European Union.
The South Plainfield, N.J.-based firm Tuesday said it was informed by the U.S. Food and Drug Administration of the tentative scheduling of a Peripheral and Central Nervous Systems Drugs Advisory Committee meeting on Sept. 28 to review the new drug application for ataluren (Translarna), a protein restoration therapy to treat nonsense mutation dystrophinopathy.
The news comes after PTC unveiled executive promotions on Monday. The company elevated Marcio Souza to chief operating officer and Christine Utter to principal financial officer and treasurer.
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