The Food and Drug Administration says that a drug proposed by GlaxoSmithKline PLC to treat a bleeding condition decreases bleeding events similar to a placebo. In documents posted to the FDA’s Web site, it’s indicated that GlaxoSmithKline’s study of the proposed drug “does not provide robust evidence” to support proposed labeling claims that it decreases the frequency and severity of bleeding in people with chronic idiopathic thrombocytopenic purpura. Chronic ITP is a condition in which the blood doesn’t clot as it should because of a lower number of blood cells called platelets. Patients with the disease tend to bleed spontaneously or after minimal trauma.
GlaxoSmithKline, the pharmaceutical giant based in London, is seeking approval for the proposed drug Promacta to treat previously-treated patients with chronic ITP. An FDA panel will decide whether to recommend approval for the drug. While the FDA doesn’t have to follow the panel’s advice, it generally does. In briefing documents, GlaxoSmithKline says there is a “high unmet medical need” for a well-tolerated short-term treatment for patients with chronic ITP. Citing the New England Journal of Medicine the company said every available treatment for patients with chronic ITP has failed to improve platelet counts. GlaxoSmithKline says its proposed drug will “effectively and consistently” raise platelet levels during short-term treatment in patients who had previously been treated for chronic ITP. According to the FDA, GlaxoSmithKline’s studies show the drug produces a trend toward reduced incidence of bleeding when compared to a placebo. The agency says, however, that this trend isn’t “statistically significant.”
Source: Wall Street Journal
Contact us today for a free legal consultation with an experienced attorney.
Fields marked *may be required for submission.
If you would like to subscribe to the Jere Beasley Report digital edition, simply visit our Subscriptions page and provide the necessary information or call us at 800-898-2034.
Attorney Advertising - Prior results do not guarantee a similar outcome.