HAE is a rare genetic disease that can be debilitating, painful and life-threatening and is characterized by local swelling in subcutaneous tissue, the gastrointestinal tract and the larynx.
In the study, patients receiving Icatibant reported an average time to onset of symptom relief as around 2 hours, a reduction in time compared to placebo.
Two studies were carried out and while the endpoint of the study was not met in one of the studies, a combined analysis of both showed a significant reduction in time to onset of symptom relief. Kos commented the failure to meet one of the targets was due to an unexpectedly high response to placebo in patients with abdominal pain.
Initial submission of a new drug application with the FDA is expected by the end of 2006. Kos collaboration partner Jerini plans to seek expedited review by FDA Icatibant has also been granted orphan drug status and fast-track designation.
“The strength and consistency of these trial results demonstrate Icatibant’s potential as a safe, effective and much needed therapy for hereditary angioedema,” said Adrian Adams, President and CEO, Kos Pharmaceuticals.
Kos has exclusive development, marketing and distribution rights for Icatibant in North America. Kos anticipates Icatibant entering a potential $300 million market space in North America, with orphan drug status securing seven-year US market exclusivity upon approval.