Affymax’s peginesatide one step closer to FDA approval

The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 15 to one, with one abstention, that peginesatide (formerly known as Hematide), demonstrated a favorable benefit/risk profile for use in the treatment of dialysis patients with anemia due to chronic kidney disease (CKD). The drug’s sponsor is US drugmaker Affymax (Nasdaq: AFFY) which has as its partner Takeda Pharmaceutical (TSE:4502), Japan’s largest pharma firm. The news pushed Affymax shares 30.5% higher to $7.65.
Given that the drug gets final FDA approval, peginesatide would compete with blockbusters such as Amgen’s Epogen (epoetin alfa), which generated $2.5 billion in revenue last year, and Johnson & Johnson’s Procrit (epoetin alfa), with 2010 sales of $1.9 billion.
“We’re encouraged by the panel’s positive view of the benefit/risk profile of peginesatide in the dialysis setting,” said John Orwin, president and chief executive of Affymax, noting that “anemia affects many patients in the dialysis setting, and we look forward to working with the FDA as they complete their evaluation of peginesatide. As a once-monthly treatment, peginesatide, if approved, has the potential to be an important option in the management of anemia in patients living with this condition.”
While the FDA is not bound by the recommendations of its advisory committees, their guidance will be considered by the FDA in its review of the New Drug Application (NDA) that was submitted for peginesatide in May 2011. The scheduled Prescription Drug User Fee Act (PDUFA) date for peginesatide is March 27, 2012.
“Today’s ODAC vote represents an important step in the peginesatide New Drug Application review process,” said Azmi Nabulsi, president, Takeda Global Research & Development Center, Inc. “As we heard from the discussion today, limited therapeutic options are available for the treatment of anemia in dialysis patients with chronic kidney disease. Affymax and Takeda will continue efforts to make this alternative available to dialysis patients and the providers who treat them,” he added.
Source: The Pharma Letter

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