Bayer finds investigational contraceptive reduces menstrual bleeding in women
BERLIN An investigational oral contraceptive reduced menstrual blood loss in women with heavy or prolonged menstrual bleeding, according to data from a late-stage clinical trial.
Bayer announced results of a placebo-controlled phase 3 trial among 231 women in Australia and Europe of Qlaira (estradiol valerate and dienogest) at the World Congress of the International Federation of Gynecology and Obstetrics Monday.
Among women in the study group, menstrual blood loss was reduced by 458 milliliters, compared with 93 milliliters in the placebo group.
“The excellent data from our phase 3 study with Qlaira clearly underscore that our new oral contraceptive could offer a new treatment option for many women who suffer from this common disorder,” Bayer Schering Pharma head of women’s health care Phil Smits said in a statement.
Bayer submitted a regulatory approval application for the drug in July seeking its approval as a contraceptive and as a treatment for heavy or prolonged menstrual bleeding.
FDA unanimously recommends GSK’s kidney cancer treatment
PHILADELPHIA A Food and Drug Administration advisory committee has recommended approval for a new kidney cancer drug.
GlaxoSmithKline announced that the FDA’s Oncologic Drugs Advisory Committee had voted unanimously to recommend approval for Votrient (pazopanib), an investigational pill-based treatment for renal cell carcinoma.
“Kidney cancer is a very serious disease, therefore the committee’s recommendation in support of pazopanib is an important step towards bringing a new, oral treatment option to advanced renal cell cancer patients,” GSK VP oncology research and development Rafael Amado said in a statement. “We look forward to working with the FDA towards the approval of pazopanib.”
The committee based its decision based on a phase 3 trial presented at the American Society of Clinical Oncology’s annual meeting this year. FDA advisory committees’ recommendations don’t guarantee full FDA approval, but are taken into account when the agency decides whether to approve a drug.
Generic drug combination cuts heart attack, stroke risk, study finds
OAKLAND, Calif. Combining two cheap generic drugs prevented more than 1,000 heart attacks and strokes, according to a study by Kaiser Permanente.
According to the study, published in The American Journal of Managed Care, 68,560 patients with diabetes or heart disease received daily 40 mg doses of the cholesterol-lowering drug lovastatin and 20 mg of the blood pressure-lowering drug lisinopril daily for three years. The combination of the drugs lowered their risk of hospitalization due to heart attack or stroke after two years by more than 60%, the study found.
It is also assumed that 75% of study participants were also taking aspirin, though aspirin was not included in the study because it is an OTC drug, and its use could not be measured through pharmacy records.
“Heart disease is the No. 1 killer in the United States, and 23 million Americans have diabetes,” Kaiser Permanente Care Management Institute diabetes clinical lead and lead study author R. James Dudl said in a statement. “This is a proven program that can be applied in many settings to reduce heart attacks and strokes, and at the same time decrease the cost of care for those events.”
The study followed 170,024 Kaiser Permanente members in California with heart disease or diabetes, dividing them into three groups: a high-exposure group of 21,292 who took the two drugs more than half of the time and 2004 and 2005 based in prescription refill habits; a low-exposure group of 47,268 who took them less than half the time; and a group of 101,464 people who didn’t take the drugs. Among the whole study population, there were 21 heart attacks per 1,000 people in 2006, but among the patients who took the drugs, there were 545 to 726 fewer heart attacks than among those who did not take the drugs.
Lovastatin is the generic version of Merck & Co.’s Mevacor, approved by the Food and Drug Administration in 1987. Lisinopril is the generic version of Merck’s Prinivil, approved the same year.