FDA OKs Drug for Paget's Disease

Reclast Approved to Treat Paget's Disease of the Bone

By Miranda Hitti
WebMD Health News

Reviewed By Louise Chang, MD

April 17, 2007 -- The FDA has approved a drug called Reclast to treat Paget's disease of the bone.

Reclast is the first new FDA-approved treatment in nearly a decade for Paget's disease of the bone, notes the drug's maker, Novartis, in a news release.

Reclast is given by infusion. Its active ingredient, zoledronic acid, is also marketed by Novartis under the brand name Zometa for use in certain cancer patients.

Reclast is the first treatment for Paget's disease patients to be given as a single dose infusion. Other treatments are oral medications that must be taken daily for up to six months, notes Novartis.

Paget's disease of the bone is a treatable, chronic disease that results in enlarged and misshapen bones in one or more areas of the skeleton, according to the web site of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).

Reclast's Trials

Novartis says the FDA approved Reclast based on efficacy and safety data from two studies.

Those studies were published in the Sept. 1, 2005, edition of The New England Journal of Medicine.

Each study lasted for six months. Together, the studies included 357 adults in 10 countries with Paget's disease of the bone.

The researchers included Ian Reid, MD, of New Zealand's University of Auckland. They randomly split the patients into two treatment groups.

Patients in one group got a single infusion of Reclast; the infusion took 15 minutes. They took pills containing no medicine (placebo) for the next 60 days.

Patients in the other group got a shot of saltwater and then took a pill called Actonel every day for 60 days.

All of the patients were followed for six months. By the end of that period, 96% of patients in the Reclast group responded to treatment, compared with 74% of those taking Actonel.

Reclast was also associated with a faster response time -- 64 days, instead of 90 days with Actonel, according to the study.

The studies show that side effects, mainly mild to moderate flu-like symptoms, were more common in the three days after the Reclast infusion. After that, the rates of adverse events were similar for both drugs.

Reclast shouldn't be taken by patients with low blood calcium (hypocalcemia), people who are hypersensitive to zoledronic acid, pregnant women, breastfeeding women, women who are planning to become pregnant, or people who are taking Zometa, notes Novartis.

SOURCES: News release, FDA. News release, Novartis. National Institute of Arthritis and Musculoskeletal and Skin Diseases: "What is Paget's Disease of the Bone?" Reid, I. The New England Journal of Medicine, Sept. 1, 2005; vol 353: pp 898-908.

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