PHARMACY

Senate report: GSK diabetes drug poses heart attack risk; draws response from drug maker

BY Alaric DeArment

RESEARCH TRIANGLE PARK, N.C. A report released over the weekend by a Senate committee linked a drug used to treat diabetes to heart attacks, prompting a denial by the drug’s manufacturer.

The Senate Committee on Finance, of which Sen. Max Baucus, D-Mont., serves as chairman and Sen. Chuck Grassley, R-Iowa, is ranking member, released the report Saturday, alleging that GlaxoSmithKline knew of heart attack risks in patients taking the diabetes drug Avandia (rosiglitazone) “several years prior” to the May 2007 publication of a study showing the link in the New England Journal of Medicine. The report was based on a two-year investigation that followed the report and included reviews of more than 250,000 documents and contacts with GSK, the Food and Drug Administration and anonymous whistleblowers.

“As a result, it can be argued that GSK had a duty to warn patients and the FDA of the Company’s concerns,” the report read. “Instead, GSK executives attempted to intimidate independent physicians, focused on strategies to minimize or misrepresent findings that Avandia may increase cardiovascular risk, and sought ways to downplay findings that a competing drug might reduce cardiovascular risk.”

GSK denied the Senate committee report’s allegations. The British drug maker said in a statement Saturday that the report was based on analyses “not consistent with the rigorous scientific evidence supporting the safety of the drug” and that it cherry-picked information from documents to mischaracterize GSK’s research efforts.

Also on Saturday, the company singled out for criticism The New York Times, which had reported the day before on confidential FDA documents from 2007 in which agency scientists had recommended Avandia’s withdrawal from the market, reporting also that the drug was linked to 304 deaths during third quarter 2009. But GSK said in its response that the FDA had since examined the available evidence, including the scientist’s assertions, and recommended that Avandia remain available.

“Contrary to the assertions in the story, and consistent with the FDA-approved labeling, the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk or causes myocardial ischemic events,” GSK said in the statement.

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Watson seeks FDA approval for depression generic

BY Alaric DeArment

MORRISTOWN, N.J. Watson Pharmaceuticals has filed a regulatory approval application with the Food and Drug Administration for a generic drug to treat depression, the generic drug maker announced Monday.

Watson filed an application for bupropion hydrobromide tablets in the 174-mg and 348-mg strengths through its subsidiary, Watson Labs Inc.-Florida. The drug is a generic version of Biovail’s Aplenzin ER, used to treat major depressive disorder.

Because Watson filed its application prior to the expiration of Biovail’s patents, Biovail filed suit against Watson Thursday in the U.S. District Court for the District of Delaware. Under the Hatch-Waxman Act of 1984, the suit places a stay of final FDA approval on Watson’s version of the drug for up to 30 months or until the two companies resolve the matter before the court.

Watson said it may be the first company to file for approval of a generic version of Aplenzin, which would allow it to compete directly with the branded version of the drug for six months following patent expiration, which will occur in 2026, according to FDA records.

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Rituxan gets nod of approval from FDA

BY Alaric DeArment

ROCKVILLE, Md. The Food and Drug Administration has approved a drug made by Roche subsidiary Genentech and Biogen Idec as a treatment for the most common type of adult leukemia, the agency announced Thursday.

The FDA approved Rituxan (rituximab) for patients with chronic lymphocytic leukemia who are beginning chemotherapy for the first time and for those who have not responded to other CLL drugs. The drug is already used to treat non-Hodgkin’s lymphoma and rheumatoid arthritis and is the third drug to win FDA approval as a treatment for CLL, after the October 2009 approval of GlaxoSmithKline’s and Genmab’s Arzerra (ofatumumab) and the March 2008 approval of Cephalon’s Treanda (bendamustine hydrochloride).

“Rituxan with chemotherapy can delay the need for additional treatment because it significantly extends the time people with CLL live without the disease worsening,” Roche and Genentech EVP global development and chief medical officer Hal Barron said in a statement. “This approval provides an important option and new hope to the many people with this incurable cancer.”

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