Amgen announces bone-strengthening drug for menopausal women
NEW YORK An Amgen drug in phase 3 trials helps to increase bone mass in menopausal women, according to a study to be presented in San Francisco Wednesday at the annual meeting of the American College of Rheumatology.
The study, which followed more than 1,000 women who had lost bone mass for more than a year, found that women who received injections of the drug denosumab every six months and an oral placebo increased their bone mass at the lumbar spine and hip by at least 3 percent, compared to women who took an injected placebo and Merck’s oral osteoporosis drug Fosamax (alendronate). All the women took daily doses of at least 500 mg of calcium and 400 mg of vitamin D.
“The fact that bone density changes were greater than the most commonly used antiresorptive agent, alendronate, shows that denosumab is an effective agent,” Chad Deal, who led the study and is head of the Center for Osteoporosis and Metabolic Bone Disease at the Cleveland Clinic, said in a statement.
Rheumatoid arthritis drugs don’t affect cancer risk, researchers find
CHICAGO Spanish researchers have found that drugs for rheumatoid arthritis called TNF blockers don’t appear to increase the risk of cancer, the researchers announced Saturday.
The drugs block a protein called the tumor necrosis factor, which is part of the immune system and is linked to arthritic inflammation. Some studies have shown that they increase the risk of cancer because they suppress the immune system, but the researchers did not find a statistical difference between the two groups of patients studied.
The research included one group of 4,500 people who took TNF blockers between 2001 and 2007, and another that included data from between 1999 and 2005 from almost 800 people who did not take the drugs.
FDA approves Barr extended-cycle oral contraceptive
MONTVALE, N.J. The Food and Drug Administration has approved a Barr Pharmaceuticals subsidiary’s application for a new oral contraceptive, Barr said Monday.
The FDA approved Duramed Pharmaceuticals’ drug LoSeasonique (levonorgestrel/ethinyl estradiol tablets and ethynyl estradiol tablets).
Barr said the drug is the first lower-dose, extended-cycle oral contraceptive. Under the extended-cycle regimen, women take combination tablets containing 0.1 mg of levonorgestrel and 0.02 mg of ethinyl estradiol for 84 consecutive days, followed by tablets containing 0.01 mg of ethinyl estradiol for seven days. The regimen is designed to reduce the number of withdrawal bleeding periods from 13 to four per year.
“As a leader in women’s health, Duramed is committed to continuing to develop new products that provide women a choice as they discuss birth control options with their healthcare providers,” Duramed chief executive officer Fred Wilkinson said.