FDA Takes More Time to Review Amgen Drug

The biotech expects a decision on the bood-platelet drug romiplostim by July 23, rather than April 23.
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Amgen

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said late Tuesday that the Food and Drug Administration will take more time reviewing the biotech company's platelet-increasing therapy romiplostim for treatment of adults with immune thrombocytopenic purpura (ITP), an auto-immune disorder.

The Thousand Oaks, Calif.-based company said that the agency will take three more months to review a risk-management program that was submitted after a March 12 FDA advisory panel voted to recommend the agency approve it. Amgen now expects a decision on romiplostim by July 23, rather than April 23.

"Amgen believes the data contained in our registrational clinical studies paired with our proposed comprehensive risk management program, together support approval by the FDA, providing ITP patients with a potential new treatment option," the company said in a press release.

About 200,000 patients in the U.S. have been diagnosed with adult ITP, according to the Platelet Disorder Support Association. The immune systems of adults with ITP destroy platelets, particularly in the spleen and sometimes in the liver. Typically, the condition is managed by a succession of treatments with a low success rate and the risk of adverse side effects.

GlaxoSmithKline

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and partner

Ligand

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also have a platelet-increasing candidate, Promacta, that is up for FDA review. The companies said in March that the FDA granted their new-drug application for Promacta priority review, or a review period shortened to six months, which is given to drugs that address significant unmet medical needs or can provide a significant improvement over currently marketed products.

Amgen shares, which closed Tuesday unchanged at $41.49, were down 3 cents at $41.46 in recent after-hours trading.