US FDA accepts Jerini's NDA for HAE drug Icatibant

The US FDA has accepted Jerini AG's New Drug Application (NDA) for Icatibant in the treatment of hereditary angioedema (HAE). The US Food and Drug Administration also designated the drug for priority review, stated a Jerini AG press release.
Priority review is granted to those products that address significant unmet medical needs and provides for a review period of six months from the date of submission. The FDA has issued an action date of April 26, 2008, under the Prescription Drug User Fee Act (PDUFA) for the NDA.

In addition, the FDA has scheduled a Pulmonary-Allergy Drugs Advisory Committee meeting on February 20, 2008, to discuss Icatibant. Advisory committees provide advice to the agency and are often held as part of the review process for first-in-class drugs. Although the committee provides advice to the agency, final decisions are made by the FDA.

"We are very pleased with the successful completion of this important regulatory step and the FDA's decision to include an advisory panel as part of the review process," said Jens Schneider-Mergener, CEO, Jerini. "We are confident that our phase III data demonstrate Icatibant's safety and efficacy in treating HAE, and we look forward to having the opportunity to present our data package to the panel.

" 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.

HAE is a debilitating and potentially life-threatening genetic disease characterized by unpredictable recurring swelling attacks of 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 of 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.