COX-2s: regulatory action to follow?
as the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) held hearings with Pfizer, Merck Sharp &
Dohme and Novartis regarding the safety over the drug class.
In the hearing that took part on 18 January, Pfizer's parecoxib and valdecoxib, Merck Sharp and Dohme's etoricoxib and Novartis' lumiracoxib, were placed under the spotlight as the Committee requested further clarifications of data from the Adenoma Prevention with Celecoxib (APC) and Prevention of Spontaneous Adenoma Polyps (PreSAP) studies.
The CHMP began this review in October 2004, when Pfizer's Celebrex (celecoxib), and Vioxx (rofecoxib), have come under fire for their cardiovascular side effects. The committee has requested further analysis of Celebrex, in particular data from the APC and PreSAP studies.
The review included Onsenal (celecoxib), used in the orphan (rare) indication in the treatment of adenomatous intestinal polyps in familial adenomatous polyposis.
This is a similar treatment area as looked at in the APC and PreSAP celecoxib studies and also the APPROVe study that led to the withdrawal of Vioxx (rofecoxib). Following discussions with the Committee, Pfizer has agreed not to launch Onsenal in the European Union pending finalisation of the assessment.
Despite there being no definite conclusions as yet, it seems likely that regulators will introduce some kind of clampdown on the products. The depth to which the situation has plummeted to ensures that the public gaze will be upon the agency like never before.
Pharma's woes have not gone unnoticed by the companies which are set to profit from the inevitable fallout as alternative therapies are sought out by doctors unsure of COX-2s. This is exemplified by the tripling of sales for Mobic (meloxicam), a non-steroidal anti-inflammatory drug (NSAID) not part of the COX-2 class.
The apparent lack of decision by the European Medicines Agency (EMEA) suggests that it may take its cue from its US equivalent. The FDA is scheduled to meet on February 16-17 to discuss the available data.
Data on other COX-2 inhibitors (etoricoxib, lumiracoxib, parecoxib and valdecoxib) was also being assessed by the CHMP, who are set to continue its discussions on the review at its next meeting on 14-17 February 2005.
