BioCryst Pharmaceuticals Inc. said a committee of the European Medicines Agency recommended the orphan drug status for the company's medicine to treat a genetic disorder.
Hereditary angioedema is a rare, genetic disorder characterized by recurrent episodes of severe swelling in the limbs, face, intestinal tract and airway.
The EMA's Committee for Orphan Medicinal Products issued a positive opinion for BCX7353 for treating hereditary angioedema. BioCryst said the positive opinion issued by the committee is expected to be adopted by the European Commission within 30 days.
Orphan drug designation in Europe is available to companies developing products intended to treat a life-threatening or chronically debilitating condition that affects fewer than five in 10,000 persons in the EU. The orphan drug status allows for financial and regulatory incentives which include a 10-year period of marketing exclusivity in the EU after product approval.
In addition, the Durham, N.C.-based biotechnology company said that the U.K.'s Medicines and Healthcare products Regulatory Agency has granted a promising innovative medicine designation to BCX7353. The company said the designation is an early indication that a medicinal product is a promising candidate for the early access to medicines scheme in the U.K.
BioCryst said the U.S. Food and Drug Administration has already granted the medicine an orphan drug designation.
