FDA close to identifying heparin contaminant
WASHINGTON Food and Drug Administration officials said that they are close to identifying the “heparin-like” contaminant found in some of the heparin causing allergic reactions, according to the Washington Post. They said that once they know exactly what the contaminant is, they will probably know whether it was deliberately added or unintentionally produced during manufacturing.
Also, the agency has said that most manufacturers have agreed to begin more sophisticated tests of heparin ingredients and products. While other manufacturers will have their tests conducted by the FDA.
Janet Woodcock, the head of the FDA’s Center for Drug Evaluation and Research, said the testing is part of a formal “import alert” and will improve monitoring of the drug. “We will get a much better picture of whether there’s any contaminant existing, and we can trace it back” to its sources,” she said.
Woodcock said that while they have not yet established a direct link between the contaminated heparin and the allergic reactions, there is now “a guilt by association.” She said the heparin-like molecule found in the contaminated lots was similar to the drug itself and was not detected until the new refined tests were developed. FDA chemists are “close to nailing down exactly what it is,” she said.
FDA to review ulcer gel, HIV medications
WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.
Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.
Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.
FDA OKs Dendreon’s phase III Provenge trial
SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.
Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.
That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.
According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.