Amgen blood-clotting drug decision delayed

Biotechnology company Amgen Inc. said Wednesday the Food and Drug Administration will not issue a much anticipated decision this week on whether to approve an experimental blood-clotting disorder drug.

The Thousand Oaks, Calif.-based company expected a decision on its Nplate drug by Wednesday, but in a statement, said there will be no decision yet. Amgen didn't disclose a reason for the delay.

"Amgen continues to work with the FDA to assist in the completion of the review process," the company said in a statement. "We remain optimistic that a final decision will be made soon, but Amgen cannot speculate on the timing of the FDA's response."

Nplate is under review as a treatment for a disorder that causes the body to attack its own platelets, which are tiny components of blood that help with clotting. The condition causes bruises and bleeding after minor injuries and affects about 200,000 people in the U.S. Amgen is targeting an adult population with a chronic form of the condition and estimates that accounts for about 60,000 patients.

The drug has already received a positive recommendation from an outside panel advisers to the FDA, setting it up for approval. The FDA generally follows its advisers' recommendations, though it is not required to do so.

Shares of Amgen fell 76 cents to $53.88 in morning trading.