FirazyrTreatment for Angioedema
Update: Firazyr (icatibant) Now FDA Approved - August 25, 2011
Complete Response to be Submitted for Icatibant Not Approvable Letter
Jerini to Submit Complete Response to the FDA for Icatibant in the Treatment of HAE
BERLIN, Germany, June 23, 2008 - Jerini AG announced today that following last week's communication with the US Food and Drug Administration (FDA), the company will submit a complete response to the FDA's not approvable letter for Icatibant in the treatment of acute attacks of hereditary angioedema (HAE). Jerini's complete response, to be submitted in the next three to four months, will provide the agency with information relating to Icatibant's efficacy in the treatment of HAE.
"The FDA has outlined specific areas of concern, which we are planning to address fully in our complete response," said Jens Schneider-Mergener, CEO of Jerini. "Having received very positive feedback from HAE-treating physicians in Europe, Jerini is well prepared for Icatibant's expected third quarter European product launch."
Icatibant, 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. Icatibant 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 Icatibant's key benefits to patients are its safety and efficacy profile demonstrated in clinical studies to date, subcutaneous administration, and room temperature stability. Icatibant 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.
About Jerini AG
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's lead compound, Icatibant, is a first-in-class compound developed for the treatment of hereditary angioedema (HAE) and European product launch is planned in the third quarter of 2008. Jerini has also established several in-house development programs, which address indications within the therapeutic areas of ophthalmology, oncology, and inflammatory disease. For more information, please see www.jerini.com. ISIN: DE0006787476 For questions, please contact: Stacy Wiedenmann Director Investor Relations & Corporate Communications Jerini AG Invalidenstr. 130 10115 Berlin T + 49 - 30 - 97893 - 285 X + 49 - 30 - 97893 - 105 firstname.lastname@example.org
Posted: June 2008
- FDA Approves Shire's Firazyr (icatibant injection) for Acute Attacks of Hereditary Angioedema (HAE) - August 25, 2011
- FDA Assigns PDUFA Date for Shire's Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema - March 21, 2011
- Shire Files Complete Response to FDA's Not Approvable Letter for Firazyr (icatibant) for the Treatment of Acute Attacks of Hereditary Angioedema - February 28, 2011
- FDA Issues Not Approvable Letter for Icatibant in the Treatment of HAE - April 24, 2008
- FDA Cancels Advisory Committee Meeting for Icatibant in the Treatment of HAE - Priority Review of Jerini's NDA Continues - January 8, 2008
- Jerini Receives NDA Filing Acceptance and Priority Review from the FDA for Icatibant in the Treatment of HAE - December 21, 2007
- Jerini Submits New Drug Application for Icatibant in the Treatment of HAE to the FDA and Requests Priority Review - October 31, 2007
- Jerini Initiates FDA Submission Process of New Drug Application for Icatibant in the Treatment of HAE - October 8, 2007