Jennifer Corbett Dooren And Jared A. Favole

A federal panel backed a proposed Amgen Inc. drug to treat a rare blood-platelet illness, and sales restrictions would be included out of concern that the drug might contribute to other serious blood disorders.

The drug would be sold under the proposed brand name Nplate to treat immune thrombocytopenic purpura, or ITP,health club an autoimmune bleeding disorder marked by below-normal levels of platelets. Platelets help form clots to stop bleeding, and Nplate is designed to increase platelet levels in a different manner than other treatments. If approved, the product would likely be injected weekly in a doctor's office.

The Food and Drug Administration panel unanimously said Nplate had a favorable risk-benefit profile; its vote amounts to a recommendation that the FDA approve the drug. The agency usually follows its panels' advice health club.

Richard Pazdur, director of the FDA's oncology product office, said the agency believes Nplate works at raising platelet levels but has safety concerns that not yet addressed from current clinical data.

The studies have involved about 300 patients treated an average of about 37 weeks health club.

Amgen has proposed a risk-management program that would restrict distribution to doctors treating patients with ITP in hopes it would discourage off-label use.

"We conclude the benefits outweigh the risks," said Dietmar Berger, Amgen's senior vice president of global regulatory affairs and safety.