PHARMACY

FDA extends NDA review for Novartis’ COPD treatment

BY Allison Cerra

BASEL, Switzerland — The Food and Drug Administration has extended its regulatory review period for Novartis’ new drug application for its once-daily, long-term maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, as well as chronic bronchitis and/or emphysema, the drug maker said.

The FDA asked for a three-month extension in order to complete its review of the new drug application for QAB149 (indacaterol) by July, stating the agency needed more time to review the submitted data. The FDA did not request additional data from the drug maker, Novartis noted.

The drug, which will be available in 75-mcg and 150-mcg strengths, was endorsed by the FDA’s Pulmonary-Allergy Drugs Advisory Committee for its safety.

"This three-month extension reflects discussion at the advisory committee based on the comprehensive clinical program, resulting in a large amount of data to be reviewed," said Trevor Mundel, global head of development at Novartis. "COPD is a life-threatening lung disease. We remain committed to bringing new therapies to patients who suffer from this condition."

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Bristol: Ipilimumab boosts survival rates among patients in phase-3 trial

BY Allison Cerra

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

The Prescription Drug User Fee Act date for the U.S. filing is March 26, Bristol said.

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GSK no longer will seek approval for Avodart

BY Allison Cerra

LONDON — GlaxoSmithKline withdrew all regulatory approval applications for a drug designed to cut men’s risk of developing prostate cancer.

The drug maker announced it no longer would pursue global approval for Avodart (dutasteride) and would work with regulatory agencies to remove the indication from the product’s license.

In late 2009, GSK began filing applications with regulatory agencies worldwide for the use of dutasteride to reduce the risk of prostate cancer. The drug maker received a complete response letter from the Food and Drug Administration’s Oncologic Drugs advisory committee this past January, which ruled against Avodart’s favorable risk/benefit profile for reduction in the risk of prostate cancer in men at risk for the disease.

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