To: Candle stick who wrote (215 ) 3/17/1998 10:33:00 AM From: targetedmoab Read Replies (1) | Respond to of 656
Immunex <IMNX.O> gets fast-track status for Enbrel SEATTLE, March 17 (Reuters) - Immunex Corp said Tuesday that the U.S. Food and Drug Administration has designated Enbrel as a "Fast Track" product for the treatment of advanced rheumatoid arthritis. Under the FDA Modernization Act of 1997, designation as a fast track product means the FDA will take steps to expedite development and review of the drug. "The designation of Enbrel as a fast track product by the FDA initiates the application and review process for Enbrel," Immunex senior vice president Dr. Ken Seamon said in a statement. He said Immunex already has submitted portions of its biologic license application to the FDA. A formal submission date will be set when the remaining portions of the application are submitted. Enbrel is being co-developed with Immunex's majority shareholder, American Home Products Corp <AHP.N>, which has marketing rights outside North America. 09:00 03-17-98 Copyright 1998 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similiar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. All active hyperlinks have been inserted by AOL.Immunex <IMNX.O> gets fast-track status for Enbrel SEATTLE, March 17 (Reuters) - Immunex Corp said Tuesday that the U.S. Food and Drug Administration has designated Enbrel as a "Fast Track" product for the treatment of advanced rheumatoid arthritis. Under the FDA Modernization Act of 1997, designation as a fast track product means the FDA will take steps to expedite development and review of the drug. "The designation of Enbrel as a fast track product by the FDA initiates the application and review process for Enbrel," Immunex senior vice president Dr. Ken Seamon said in a statement. He said Immunex already has submitted portions of its biologic license application to the FDA. A formal submission date will be set when the remaining portions of the application are submitted. Enbrel is being co-developed with Immunex's majority shareholder, American Home Products Corp <AHP.N>, which has marketing rights outside North America. 09:00 03-17-98 Copyright 1998 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similiar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. All active hyperlinks have been inserted by AOL.