Jerini Receives EMEA Filing Acceptance of its Marketing Application for Icatibant in the Treatment of Hereditary Angioedema
- Category: Proteins and Peptides
- Published on Friday, 17 August 2007 04:00
- Hits: 1496
BERLIN, Germany | August 16, 2007 | Jerini AG (FSE:JI4) announced today the acceptance of its Marketing Authorization Application (MAA) by the European Medicines Evaluation Agency (EMEA) on August 15, 2007 for Icatibant in the treatment of hereditary angioedema (HAE). The agency’s Committee for Medicinal Products for Human Use (CHMP) has also granted Jerini accelerated assessment for the review of this submission, which shortens the regulatory review period from 210 to 150 calendar days and is granted to drug candidates addressing major public health interest and therapeutic innovation. The start of Jerini’s EMEA regulatory review period begins on August 15, 2007, and an opinion from the agency’s committee could be received as early as first quarter 2008. EMEA approval provides marketing authorization in all 27 EU member states as well as Norway, Iceland, and Liechtenstein.
“We are very excited to have received filing acceptance from the EMEA. This milestone along with our accelerated assessment status provides clarity for our regulatory timeline moving forward,” said Jens Schneider-Mergener, CEO of Jerini. “Jerini is very confident that we can provide HAE patients with an exciting new treatment concept in the near future. Icatibant is the first-in-class bradykinin antagonist which, when approved, will enable this patient group to better manage their disease, thereby improving their quality of life. ”
Icatibant, a synthetic peptidomimetic, 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. Icatibant has been granted orphan drug status for the treatment of angioedema by the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), potentially securing, upon approval, market exclusivity for seven and ten years, respectively. In addition, the FDA has granted fast-track designation to Icatibant in the indication HAE.
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 hands, face, 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 programs, as well as others in collaboration with established partners. Jerini has completed Phase III clinical trials of Icatibant in the subcutaneous treatment of hereditary angioedema. The company’s marketing authorization application has been accepted for review by the EMEA and granted accelerated assessment by the agency, shortening the regulatory review period from 210 to 150 calendar days. Jerini plans to complete US submission to the FDA in the third quarter of 2007. Based on its technology platform, Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease.
SOURCE: Jerini AG