Amgen Inc.’s anemia drugs Epogen and Aranesp are being rivaled by Affymax Inc., whose experimental anemia medicine has been found to be equally effective, the FDA said today.
Johnson & Johnson also markets Procrit for patients with chronic kidney disease. The news caused Affymax’s shares to experience their biggest increase in 16 months, Reuters reports.
The therapy chemically known as peginesatide is “non- inferior” to Epogen, Aranesp and Procrit, FDA staff, evaluating whether the product should be sold, said in a report.
Agency reviewers also decided the treatment is as safe as Epogen and Procrit for people on dialysis, the patient group for whom Affymax seeks approval.
An advisory panel is scheduled to meet Dec. 7 to evaluate the findings, with a final decision from the agency expected by March 27, reports Reuters.
California-based Affymax’s peginesatide, the company’s first product if approved, would compete with drugs such as Epogen, which generated sales of $2.5 billion in 2010.
According to Affymax’s September quarterly report, the effects of peginesatide last longer, making it more convenient and less expensive.
The drug can used once monthy, compared with Epogen, which requires an initial dose of three times weekly, Reuters reports.
Affymax shares climbed 14 percent to $5.98 at 9:40 a.m. after rising 26 percent to $6.59 in the drugmaker’s biggest one-day increase since August 2010.
