الخميس, 24 أيار 2012 3. رجب 1433
Shares in Affymax climbed 10 percent Thursday after the company announced that it and partner Takeda expect to file for FDA approval Hematide (peginesatide) in the first half of 2011 for the treatment of anaemia in patients with chronic kidney failure.
Affymax said that before year end it would meet with US regulators to discuss a registration strategy for the drug and, subject to feedback, file for approval of the drug for the treatment of anemia in patients receiving dialysis in 2011.
In June, the companies released data from a late-stage clinical programme demonstrating that while Hematide was effective, a subgroup of patients not on dialysis experienced more heart-related side effects, including irregular heart rhythm and death.
Affymax said the companies would continue to evaluate Hematide in the non-dialysis indication