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Theranexus has obtained an orphan drug designation from the FDA for THN102 in the treatment of narcolepsy

logo-theranexusA first step towards the company’s ambition of securing development and marketing of THN102 in the USA.

 


 

Lyon, October 4th 2016 – Theranexus, a clinical-stage biopharmaceutical company, announced today that it’s most advanced drug candidate, THN102, has received an Orphan Drug Designation (ODD) from the American regulatory agency, the FDA, for the treatment of narcolepsy, a rare and highly debilitating sleep/wake disorder.

 

The Orphan Drug Designation (ODD) may be granted to drugs that are intended to improve the quality of life of patients affected by rare diseases and conditions that affect less than 200,000 people in the United States. This designation grants Theranexus some interesting incentives: especially, 7 years of exclusive marketing rights in the United States upon FDA approval, as well as an exemption from certain registration fees.

 

 

Read the press release