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Miravant eyes priority review for SnET2

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Miravant is requesting a priority review for its SnET2 (rostaporfin) for treatment of wet age-related macular degeneration with any classic component. The March 31 submission meets the firm's previously announced first-quarter 2004 filing target (1Pharmaceutical Approvals Monthly Dec. 1, 2003, p. 7). The NDA is based on subset analyses of Phase III studies; Pharmacia opted out of its development agreement in January 2002 when the photodynamic therapy did not meet the primary endpoint in the overall study population. A Premarket Approval Application for the ophthalmic laser that activates rostaporfin was submitted in conjunction with the NDA...
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