Merck's Arcoxia (etoricoxib) NDA was "approvable" at FDA Oct. 28.

The agency is seeking additional safety and efficacy data for the COX-2 inhibitor, the company said.

Merck withdrew its Arcoxia predecessor agent Vioxx (rofecoxib) Sept. 30 after data from the APPROVe study found an increased risk of cardiovascular adverse events associated with the drug (¹ [A#14040930002]).

Merck submitted a revised NDA for Arcoxia on Dec. 30, 2003 to include efficacy data for ankylosing spondylitis and to provide additional cardiovascular safety data.

The company is seeking indications for the treatment of osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea, acute gouty arthritis and ankylosing spondylitis.

Merck presented 12-month data from its EDGE trail (Etoricoxib-Diclofenac Gastrointestinal Evaluation) at the American College of Rheumatology meeting Oct. 19.

The trial showed a statistically significant increase in the rate of dropouts due to hypertension with etoricoxib patients (2.3%) compared to diclofenac patients (0.7%).

EDGE data did not show a statistically significant difference in cardiovascular adverse events.

Merck is working with international regulatory agencies on labeling changes for Arcoxia to address the safety issues that prompted the Vioxx withdrawal (² Also see "Arcoxia Safety Can Be Addressed In Labeling, Merck Says" - Pink Sheet, 13 October, 2004.).

FDA plans to hold an advisory committee meeting in early 2005 to discuss the cardiovascular safety profile of COX-2 inhibitors (³ Also see "FDA To Hold COX-2 Advisory Committee In Early 2005, Woodcock Says" - Pink Sheet, 19 October, 2004.).

- John Rancourt

Merck’s Arcoxia “Approvable” At FDA

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