New ITP Drug Approved By The FDA

By Michael Todd
12:30, August 25th 2008
25 votes
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New ITP Drug Approved By The FDA

The Food and Drug Administration approved on Friday Nplate, a drug produced by Amgen Inc. which stimulates bone marrow to produce blood platelets for patients suffering from chronic immune thrombocytopenic purpura (ITP).

The drug will be available in the United States and it is expected to offer new solutions for patients who have lost hope when the other available treatments failed. The alternatives include immune-suppressing drugs, steroids and surgery. The news about the approval of Nplate was received with great enthusiasm, as the treatments mentioned above turned out to be unsuccessful for long-term use in most of the cases. The FDA approved it only for the patients who did not respond to the other treatment plans.

"This product is important in that it offers a new approach to the treatment of patients with an uncommon blood disorder who are often very ill," explained Dr. Janet Woodcock, head of the FDA's Center for Drug Evaluation and Research.

The drug’s producer, Amgen, explained that Nplate is the result of more than 15 years of research and that it is confident in the drug’s healing effects.

The condition affects more than 140,000 people and involves immediate bruising and bleeding after minor injuries. Also, it is known to cause nose bleeding and bleeding gums and its complications include subarachnoid and intracerebral hemorrhage.

Amgen Inc. is a well known international biotechnology company, with its main office situated in Thousand Oaks, California. It produces a wide variety of drugs, including Epogen, Enbrel, Neulasta, Neupogen, Aranesp and its staff registers more than 14,000 employees.



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