Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE®) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, the Company announced that perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "This Fast Track designation can significantly reduce the FDA review time of a new drug application, and therefore can expedite the time to market for perifosine in multiple myeloma." Mr. Bentsur added, "We believe that the Fast Track designation, together with the SPA and Orphan Drug status previously granted to us by the FDA for perifosine in multiple myeloma, significantly enhances the value proposition of perifosine in this indication. We are eager to begin the Phase 3 trial later this month."
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
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