Merck revises Arcoxia NDA
Executive Summary
Merck is withdrawing the NDA for its COX-2 inhibitor Arcoxia (etoricoxib) and refiling with additional ankylosing spondylitis efficacy data. "Merck believes the new data, along with the data previously submitted, will provide a fuller picture of the product's safety and efficacy and will position it more favorably for approval in the U.S." Additional studies are not needed; Merck has the ankylosing spondylitis data on hand. Merck filed the Vioxx follow-on Oct. 11. Arcoxia may be reviewed by FDA's Arthritis Advisory Committee in mid-May (1"The Pink Sheet" March 4, In Brief)...
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Merck is withdrawing the NDA for its COX-2 inhibitor Arcoxia (etoricoxib) and refiling with additional ankylosing spondylitis efficacy data. "Merck believes the new data, along with the data previously submitted, will provide a fuller picture of the product's safety and efficacy and will position it more favorably for approval in the U.S." Additional studies are not needed; Merck has the ankylosing spondylitis data on hand. Merck filed the Vioxx follow-on Oct. 11. Arcoxia may be reviewed by FDA's Arthritis Advisory Committee in mid-May (1 'The Pink Sheet' March 4, In Brief).... |