Novartis's Tasigna gets first approval
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ZURICH, July 25 (Reuters) - Novartis's (NOVN.VX) cancer treatment Tasigna has received approval in Switzerland, its first certification worldwide, the Swiss drugmaker said on Wednesday.
"The approval of Tasigna came after an accelerated review by the Swiss health authority Swissmedic based on positive findings from a pivotal Phase II trial," Novartis said.
Novartis has been under pressure as a number of drugs are facing delays.
Last week the company said U.S. regulators had extended the review period for Tasigna by three months to analyse additional data.
Novartis said on Wednesday that it expected decisions on Tasigna in the United States and Europe in 2007 and it had filed the drug for submission in Japan in the second quarter 2007.
More Phase III studies involving Tasigna and patients with chronic myeloid leukemia were planned for 2007, Novartis said.
"A registration study is already underway in patients with gastrointestinal stromal tumors (GIST), which can also be treated with Glivec in certain countries," the company said.
((Reporting by Sven Egenter; editing by Paul Bolding;
Email: sven-markus.egenter@reuters.com
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Telephone: +41.44.631.7351)) Keywords: NOVARTIS TASIGNA/
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