LONDON, July 19 (Reuters) - Novartis AG's NOVN.VX experimental diabetes drug Galvus has been recommended for approval in Europe, lifting prospects for a medicine that faces a lengthy delay in getting to market in the United States.
Thursday’s decision by a committee of experts at the European Medicines Agency comes two days after Novartis said it would not be ready to resubmit Galvus to U.S. regulators until mid-2009, following a request for more safety data.
The agency’s Committee for Medicinal Products for Human Use (CHMP) also backed the Swiss group’s Exelon Patch, which delivers a treatment for Alzheimer’s disease through a skin patch, and once-yearly Aclasta for women with postmenopausal oesteoporosis.
Recommendations for marketing approval by the agency’s Committee for Medicinal Products for Human Use are normally endorsed by the European Commission within a couple of months.
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