The U.S. Food and Drug Administration announced that it found that Promacta does not significantly lower bleeding in patients with rare blood disorders.
FDA reviewers stated that upon review of company studies that Promacta, an experimental drug from GlaxoSmithKline, was not found to help control the severity and frequency of bleeding as purported by the company. Of the two studies submitted by GlaxoSmithKline, neither showed a significant difference between patients receiving Promacta and those that received a placebo.
GlaxoSmithKline had applied for a New Drug Application for Promacta (eltrombopag olamine) with the FDA in December of 2007 and had released previous reports that the drug had decreased bleeding in previous trials.
The drug was intended to treat idiopathic thrombocytopenic purpura which is an immune system disorder that causes the body to destroy its own platelets. The disorder can be serious enough, though rarely, to cause fatal hemorrhaging in the brain.
[Source: ADrugRecall]
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» Outside Panel Reviews Promacta from PharmaGazette
Yesterday I brought you an article about a new experimental drug from GlaxoSmithKline called Promacta. Its purpose is to lower bleeding in patients with rare blood disorders but the U.S. Food and Drug Administration released a report stating that the... [Read More]
Tracked on: June 12, 2008 12:06 AM | Permalink to Trackback