MSD: CHMP recommends extension of Arcoxia indications

Merck, Sharp and Dohme (MSD) has announced the conclusion of the review of Arcoxia (etoricoxib) the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The committee review found the benefits of Arcoxia 90mg to outweigh the risks of the drug as a treatment for rheumatoid arthritis and ankylosing spondylitis and recommended an extension of the indication of the compound to include the latter condition at this dose.

Furthermore, the CHMP also recommended a strengthening of the existing label contraindication and the addition of warnings for uncontrolled hypertension patients.

Following the predicted adoption of the CHMP opinion by the European Commission the referral outcome will apply to all 27 EU member states in addition to Iceland and Norway.

“MSD considers that this comprehensive review of the use of Arcoxia in rheumatoid arthritis and ankylosing spondylitis affirms the value of this therapeutic option for patients with these debilitating diseases, in addition to osteoarthritis and acute gouty arthritis,” the company said,

It added its resolution to continue its collaboration with the committee to provide extra data and information on the compound.

In August 2006, MSD said Arcoxia has similar rates of cardiovascular events to comparable existing treatments.