ViroPharma Incorporated has announced that the European Medicines Agency (EMA) has accepted the filing of its Marketing Authorization Application (MAA) for Cinryze for acute treatment and prophylaxis against hereditary angioedema (HAE), which was submitted through the centralized procedure in March 2010.
ViroPharma is seeking European approval for both prevention and treatment of acute attacks of hereditary angioedema (HAE).
Cinryze was approved by the U.S. Food and Drug Administration in October 2008 for routine prophylaxis against angioedema attacks in adolescent and adult patients with HAE. It is currently not approved for use in acute attacks of HAE in the U.S.
“Hereditary angioedema is a genetic inflammatory disease suffered by patients across the globe, and the acceptance of this application by the EMA is an important step in the process towards bringing this important therapy to HAE patients in Europe suffering from this debilitating disease,” commented Vincent Milano, ViroPharma’s president and chief executive officer. “We are looking forward to the day when we may be in position to provide this therapeutic alternative to this additional group of HAE patients.” The MAA is based on comprehensive clinical data including analyses of the results of ViroPharma’s Phase 3 studies of acute and prophylactic use of Cinryze in patients with HAE, plus recent data from the company’s longer-term open label studies of the drug. The MAA acceptance triggers the initiation of EMA’s regulatory review process.
In 2009 Cinryze received orphan medicinal product designation in the European Union. In the E.U., orphan medicinal product designation is conferred upon investigational products for diseases that affect fewer than five in 10,000 patients. Products with orphan designation that are the first to be approved for a specific indication receive ten years of market exclusivity in the European Union plus two additional years with approval of a Pediatric Investigation Plan. In March of 2010, ViroPharma announced the adoption of a positive outcome to the compliance check for its Pediatric Investigation Plan for Cinryze.