Novartis files application with FDA for Zometa

by Medindia Content Team on  September 1, 2001 at 5:03 PM Drug News   - G J E 4
Novartis files application with FDA for Zometa
Novartis Pharmaceuticals has submitted an application to the Food and Drug Administration, seeking marketing authorization for Zometa in the treatment of bone complications associated with a broad range of tumor types. These include prostate and lung cancer, for which no bisphosphonate therapy is currently approved. The spread of cancerous cells from the original tumor to the bone, can lead to serious complications called skeletal related events like fractures, compression of the spinal cord, severe bone pain and hypercalcemia.

Zometa is a new generation intravenous bisphosphonate that was approved by the FDA just two weeks ago (20 August 2001) for the treatment of hypercalcemia of malignancy (HCM), the most common life-threatening metabolic complication of cancer. To date, Novartis has received marketing clearances for Zometa in the treatment of hypercalcemia of malignancy (HCM) in more than 30 countries.

"Bone complications can be extremely debilitating to cancer patients, and seriously impact their day to day activities. Zometa offers these patients an effective treatment with a convenient 15-minute infusion time. Novartis is pleased to bring forward another drug that will help make a marked difference in the lives of cancer patients and their families" said David Epstein, President, Novartis Oncology.

Three trials have been successfully conducted, evaluating more than 3,000 patients. This is the largest set of clinical trials ever conducted to evaluate the efficacy and tolerability of bisphosphonates in treating bone complications.


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