![From QSR to QMSR: Meeting FDA’s New Requirements From QSR to QMSR: Meeting FDA’s New Requirements](https://www.fdanews.com/ext/resources/Book-Covers-NEW/From-QSR-to-QMSR-500.png?height=200&t=1714569011&width=200)
Home » KOS ANNOUNCES RESULTS FOR HEREDITARY ANGIOEDEMA TRIAL
KOS ANNOUNCES RESULTS FOR HEREDITARY ANGIOEDEMA TRIAL
September 22, 2006
Kos Pharmaceuticals has announced preliminary results from two Phase III trials of Icatibant, FAST-1 and FAST-2, for the subcutaneous treatment of hereditary angioedema (HAE), a genetic disease. The primary study endpoint was met in FAST-2; and while it was not met in FAST-1, combined analysis of both studies showed a significant reduction in time to onset of symptom relief for patients receiving Icatibant versus those receiving placebo or comparator as measured by a visual analog scale (VAS). The company expects to apply for FDA approval in December.
Patients receiving Icatibant reported a median time to onset of symptom relief of 2.5 hours in FAST-1 compared with a median time of 4.6 hours for those receiving placebo. A median time of 2.0 hours was reported by patients receiving Icatibant in FAST-2, compared with 12 hours by those receiving the comparator, tranexamic acid. A total of 56 patients participated in FAST-1, a double-blind, placebo-controlled study conducted in the United States, Canada, Australia and Argentina. The FAST-2 trial treated a total of 74 patients in 10 European countries and in Israel in a double-blind study against the comparator, tranexamic acid. An aggregate of 231 open-label treatments were administered in both trials. The median time to first improvement, as reported by patients receiving Icatibant in the FAST-1 and FAST-2 studies, was consistent with Phase II study results.
Icatibant is a specific peptidomimetic bradykinin B2 receptor antagonist developed by Jerini. The drug has been granted orphan drug status and fast-track designation by the FDA. HAE is the first of several indications for which Icatibant offers a potential treatment, and Kos' partnership with Jerini allows for ongoing potential clinical development in other forms of angioedema, asthma and liver cirrhosis. Kos has exclusive development, marketing and distribution rights for Icatibant in North America.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct