Study of Copaxone reveals that drug is not effective for patients in treatment of ASL
WASHINGTON Copaxone, a blockbuster drug manufactured by Israel’s Teva Industries, has proven to be ineffective for the treatment of amyotrophic lateral sclerosis, according to the company.
Copaxone, which earned Teva $436 million in revenue, was subjected to a 366-patient Phase II trial to investigate if it was able to reduce deterioration in patients with ALS. According to published reports, the study showed that the drug, although safe, did not increase rate of survival among patients battling the disease.
ALS, commonly known as Lou Gehrig’s disease, plagues about 10,000 people in the U.S. and Europe. ASL leads to paralysis, and those who are diagnosed are expected to live within 3-5 years experiencing weakness in limbs, twitching and respiratory impairment, as well as other painful symptoms. Copaxone was the leading therapy for multiple sclerosis in the U.S., but based on the new findings, Teva will continue to search for other options in treating the disease.
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.