U.S. approves Novartis once a year osteoporosis drug
WASHINGTON (Reuters) - Swiss drugmaker Novartis A said Friday it had won U.S. approval to sell the first once-a-year treatment for the bone-thinning disease osteoporosis.
The drug, Reclast, is administered annually in a 15-minute infusion for women with post-menopausal osteoporosis.
It will compete with osteoporosis pills that are taken daily, weekly or monthly.
Not all women take those medicines regularly, which reduces their effectiveness for preventing bone fractures.
Novartis said Reclast could help overcome that problem with its once-a-year dosing.
"For the first time we can ensure women receive a full year of the treatment they need to protect their bones," Dr. Felicia Cosman, an osteoporosis specialist at Columbia University, said in a Novartis statement.
Reclast reduced the risk of spine fractures by 70 percent in a company-funded study of more than 7,700 women that was published earlier this year in The New England Journal of Medicine.
Conventional oral drugs typically produce a 40 percent to 50 percent reduction in spinal fractures.
In the Reclast study, about 11 percent of patients who got a placebo had a fracture over three years, compared with 3.3 percent who received the drug.
The study raised a concern about serious cases of atrial fibrillation, a type of abnormal heart rhythm.
About 1.3 percent of Reclast patients had that problem, compared with 0.4 percent of placebo patients.
Novartis said the timing suggested the cases were not related to the drug.
Most surfaced more than 30 days after the infusion.
The problem was not seen in other studies or with Zometa, a Novartis cancer drug that contains the same active ingredient as Reclast called zoledronic acid.
Reclast already is sold in the United States for treating a bone disorder called Paget's disease.
The drug is part of a class of osteoporosis medicines called bisphosphonates. Other oral drugs in the same family include Merck & Co Inc.'s Fosamax and Roche Holding AG and GlaxoSmithKline Plc's Boniva and Actonel, sold by Procter & Gamble and Sanofi-Aventis.
Bisphosphonate pills are supposed to be taken on an empty stomach with a full glass of water, and patients must remain upright for at least 30 minutes.
Reclast is sold outside the United States as Aclasta.
