FDA approves Watson’s generic version of Boniva
PARSIPPANY, N.J. — The Food and Drug Administration has approved Watson’s generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.
Watson announced the FDA’s approval of ibandronate tablets in the 150-mg strength, a generic version of Genentech’s Boniva. Watson plans to launch its version in second quarter 2012.
On Monday, the FDA approved generic ibandronate tablets in the same strength made by Mylan, Apotex and Orchid Healthcare. Boniva had sales of $510 million during the 12-month period ended in January, according to IMS Health.
Watson said Roche, Genentech’s parent company, had filed suit against it with regard to the drug, alleging patent infringement.
FDA advisory committee votes in favor of GSK’s Votrient
PHILADELPHIA — A Food and Drug Administration expert panel delivered a favorable vote on a cancer drug made by GlaxoSmithKline.
GSK announced that the FDA Oncologic Drugs Advisory Committee voted 11-2 that clinical trial data indicated a favorable risk-benefit profile of the drug Votrient (pazopanib) in patients with advanced soft-tissue sarcoma who have received chemotherapy. The drug is already approved for treating the kidney cancer renal cell carcinoma.
"Treatment options for patients with advanced soft-tissue sarcoma are limited," GSK Oncology SVP Rafael Amado said. "We are therefore pleased that the committee took a favorable view of the clinical data for Votrient."
The FDA is not bound by advisory committee votes when deciding whether or not to approve a drug but usually follows them.
Study examines long-term efficacy of dapagliflozin use in Type 2 diabetes management
NEW YORK — An investigational Type 2 diabetes drug may improve glycemic control among patients that are unable to improve their blood sugar with high doses of insulin alone, according to a new study.
Published in the Annals of Internal Medicine, researchers led by John Wilding of University Hospital Aintree in Liverpool, England, found that when Type 2 diabetes patients added dapagliflozin — a selective inhibitor of sodium-glucose cotransporter 2 — in either 5-mg or 10-mg strengths to their daily medication regimen, the patients saw a reduction in their hemoglobin A1C levels and weight at 24 weeks, compared with those who added placebo. These results were maintained by the 48th week of the study; however, patients in the pooled dapagliflozin groups had a higher rate of hypoglycemic episodes (56.6% versus 51.8%), events suggesting genital infection (9% versus 2.5%) and events suggesting urinary tract infection (9.7% versus 5.1%). A total of 800 patients were analyzed in the study.
The researchers added that the study "was not designed to evaluate long-term safety."
The primary funding sources for the study were drug makers AstraZeneca and Bristol-Myers Squibb, which filed for regulatory approval for dapagliflozin with the Food and Drug Administration. In January, the agency declined to approve the drug.