| MSD: European comission adopts EMEA Arcoxia recommendations. | Posted on 01/10/2008 in Pharmaceutical Company Product News Merck, Sharp and Dohme (MSD) has announced the European commission has adopted the recommendations of the European Medicines Agency (EMEA) on Arcoxia (etoricoxib) 90mg.
This means the compound is now approved as a once-daily treatment for ankylosing spondylitis, with the 90mg dose being maintained for rheumatoid arthritis.
Furthermore, the warnings and contraindications sections of the label for the drug will be modified for the monitoring and treatment of patients of hypertension.
MSD said Arcoxia is a non-steroidal anti-inflammatory drug (NSAID) which operates through the inhibition of the enzyme responsible for inflammation and pain known as cyclooxygenase-2.
Clinical trials have shown such drugs to be associated with an increased risk of myocardial infarction and stroke relative to some other NSAIDs and placebo.
"The commission's action affirms the value of Arcoxia as a therapeutic option for the treatment of a broad range of conditions," MSD said.
The company added the compound is indicated as a treatment for osteoarthritis in either 30mg or 60mg doses, for rheumatoid arthritis in a 90mg dose and acute gouty arthritis in a 120mg dose.
MSD said the national approval procedures to implement these changes will soon begin in all 27 EU member states.
In July 2008, a review by the Committee for Medicinal Products for Human Use of the EMEA found the benefits of Arcoxia 90mg outweighed the risks for patients with ankylosing spondylitis and rheumatoid arthritis.Other news stories from 01/10/2008
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