Novartis AG said Thursday the U.S. Food and Drug Administration approved the osteoporosis drug Reclast which prevent new fractures in patients following a hip fracture.
The drug approved is the first osteoporosis treatment that has demonstrated a reduction of new clinical fractures in patients who have recently a low trauma hip fracture, Novartis said in a statement.
The FDA approval decision for Reclast was based on safety and efficacy data from a Recurrent Fracture Trial that showed a significant 35 percent reduction of risk.
Reclast, whose active ingredient is zoledronic acid, builds bone and is given annually in a 15-minute intravenous infusion. It is already approved in the United States and Europe used to reduce risk of fractures in patients with Osteoporosis.
In the United States, around 10 million people suffer from Osteoporosis, an illness which causes bones to become weak and are vulnerable to break.
Shares of Novartis were trading at $52.69 in the New York Stock Exchange afternoon trading, going up 0.5 percent.