UPDATE 1-US FDA approves Baxter drug Ceprotin for clotting

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WASHINGTON, March 30 (Reuters) - The U.S. Food and Drug Administration said on Friday it approved a Baxter International Inc. (BAX.N) drug, Ceprotin, for treating patients with a rare clotting disorder.

Ceprotin is made from the plasma of healthy human blood donors and is a concentrated form of a substance normally manufactured in the liver. The substance, known as Protein C, is important in controlling blood coagulation and prevents the formation and growth of blood clots.

"This product offers much-needed treatment for the small number of patients with severe inherited Protein C deficiency," said Dr. Jesse Goodman, director of FDA's Center for Biologics Evaluation and Research. "If left untreated, clotting may result in blindness, severe brain damage, multi-organ failure and death for these patients."

Patients with severe inherited Protein C deficiency must take oral or injected anticoagulant drugs regularly to avoid blood clots.

The FDA granted Ceprotin orphan drug status, which provides the manufacturer with financial incentives to develop a drug or biologic to treat a rare disease affecting fewer than 200,000 people in the United States.

Severe congenital Protein C deficiency is a rare genetic defect found in one to two newborns for every 1 million births.

Ceprotin can be used to treat the patients when they face a life-threatening situation from blood clots in the veins, or a severe skin and systemic blood clotting disorder known as Purpura fulminans, the FDA said.

Baxter enrolled all available patients for a trial and found Ceprotin was effective in 94 percent of them with Purpura fulminans, the FDA said. According to the agency, the most common adverse reactions were rash, itching and lightheadedness.

((Reporting by Julie Vorman, editing by Toni Reinhold; julie.vorman@reuters.com, +1 202 898 8467)) Keywords: BAXTER CEPROTIN/

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