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On Friday, the Food and Drug Administration (FDA)
gave its approval for Amgen Inc.'s drug called Nplate, therefore it will be
made available for U.S. residents soon enough.
The administration acknowledged the efficiency
and lack of risks associated with the use of the new drug, which can be used
for treating a clotting disorder that causes massive bleeding.
According to the FDA, the way the injectable
drug works is it stimulates bone marrow which then produces blood platelets;
Nplate will be very useful for patients diagnosed with chronic immune
thrombocytopenic purpura (ITP).
Dr. Janet Woodcock, head of the FDA's Center
for Drug Evaluation and Research, said the new drug is important because it
provides an innovative approach to the treatment of the rare blood disorder.
Amgen Inc. said the costs of the Nplate
treatment will probably be very close to the costs of "standard treatment
regimens."
The FDA’s decision followed the failure of
several other treatments which addressed the condition. Before the approval, two
studies on 125 patients have been carried out over a six month period. From now
on, the doctors who prescribe Nplate and the patients who benefit from the drug
will have to be included in a special registry which will eventually provide
long-term safety related information.
According to the company, there are currently
around 60,000 U.S. adults suffering from chronic ITP. Starting from these
numbers, certain analysts said the drug could generate revenues ranging from
$66 million to $117 million in 2009.
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