Guest guest Posted February 27, 2007 Report Share Posted February 27, 2007 TOKYO, Feb 26 - Astellas Pharma Inc. Japan's third-largest drug maker, said on Monday a committee of the European Medicines Agency had recommended marketing approval of a once-daily version of its key transplant drug Prograf. The new formulation is a modified release version of Prograf which is used to prevent organ rejection in kidney, liver and heart transplants and is currently taken twice a day. Prograf is expected to account for 19 percent of Astellas' overall revenue this year, and gaining approval of the new formulation is key for the company to minimise the impact of generics when the drug's patent expires. The drug will come off patent in Europe in June 2009 and in the United States in April next year. In January, the U.S. Food and Drug Administration said it could not yet approve the new version of the drug for heart transplant patients and raised questions about its application for use of the drug in kidney and liver transplants. The " action letter " from the FDA will mean a delay of at least six months, at which point the agency will either approve the drug or send another letter requesting more information. Immunosuppressant drugs are different from other drugs in that the risk of organ rejection means doctors are more cautious about using generics, and analysts say any fall in profit would be gradual, giving Astellas more time to gain approval. Reuters 2007. All rights reserved. Reuters Pictures Editors Choice: Best pictures from the last 24 hours. View Slideshow Quote Link to comment Share on other sites More sharing options...
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