BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) rose Monday on approval for one of its products.
BioCryst, last week said French National Agency for Medicines and Health Products Safety has granted an Autorisation Temporaire d'Utilisation de cohorte (cohort ATU), or Temporary Authorization for Use, for the use of berotralstat to prevent attacks of hereditary angioedema (HAE) in appropriate patients aged 12 and older.
This cohort ATU allows patients with HAE in France to receive treatment with berotralstat before the drug is granted marketing authorization by the European Commmission (EC).
According to the the French Code of Public Health, a cohort ATU is dedicated to high unmet medical needs in serious diseases and covers medicinal products of which the efficacy and safety of use are strongly presumed and intended for a group or sub-group of patients treated and monitored in accordance with criteria defined in a protocol for therapeutic use and collection of information.
Berotralstat is the first and only oral therapy designed specifically to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.
BCRX shares gained 21 cents, or 1.7%, in Monday’s first hour of trading to $12.85.
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