FDA Clears Novartis’ Bone Drug Reclast

Novartis said Tuesday the U.S. Food and Drug Administration approved Reclast for treating the bone condition Paget’s disease.

We believe Reclast provides a critical new treatment option for people who suffer from Paget’s disease, said James Shannon, Novartis’ head of development. Furthermore, we are exploring the full clinical potential of this agent in treating other metabolic bone diseases, including postmenopausal osteoporosis.

Novartis said Reclast is the first new treatment approved in nearly a decade for Paget’s disease, a painful bone disorder that causes abnormal bone growth and can lead to weak and brittle bones. Current therapies are given orally daily for up to 6 months, but Reclast is given as a single dose infusion.

The most common side effects associated with Reclast include fever, pain in the muscles, bones or joints, fatigue and headache.