Jerini AG announced that the European Commission has granted the company marketing authorization for Firazyr (Icatibant) in the treatment of acute attacks of hereditary angioedema (HAE).
The European Commission's approval allows Jerini to market Firazyr in the European Union's 27 member states, making it the first product to be approved in all EU countries for the treatment of HAE.
"The European Commission's approval of Firazyr is a pivotal milestone for Jerini as a company," said Jens Schneider-Mergener, CEO of Jerini. "Our sales and marketing team is ready to make Firazyr available to HAE patients in all 27 EU countries, giving them access to an innovative treatment for their disease."
Firazyr, a synthetic peptidomimetic, is a first-in-class compound, which works by blocking the B2 receptor as an antagonist to the peptide-hormone bradykinin. Bradykinin has been shown to be elevated in HAE patients and responsible for edema formation during HAE attacks. Firazyr has been granted orphan drug status for the treatment of angioedema by the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA), potentially securing, upon approval, market exclusivity for ten and seven years, respectively. Among Firazyr's key benefits to patients are its safety and efficacy profiles as demonstrated in clinical studies to date, subcutaneous administration, and room temperature stability. Firazyr will be packaged in a pre-filled syringe.
HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks in the hands, feet, face, larynx, and abdomen. It is estimated that approximately 10,000 patients in the United States and Europe have been diagnosed with HAE. HAE attacks affecting the face, hands, and feet can be disfiguring, while attacks in the gastrointestinal tract result in severe pain caused by swelling in the intestinal wall. Attacks that affect the larynx are life-threatening because swelling of the larynx constricts the upper airways and can lead to death by suffocation. The prevalence of HAE is estimated between one in 50,000 and one in 10,000 individuals, and it is estimated that between 15,000 and 75,000 people are affected with HAE in the European Union and the United States.
Jerini is a pharmaceutical company based in Berlin, Germany, focusing on the discovery, development, and commercialization of novel peptide-based drugs. The company pursues disease indications that have limited or no treatment options and has built a drug pipeline composed of its own programmes, as well as others in collaboration with established partners.