The FDA decision is another major blow for Pfizer. At best parecoxib’s path to approval will now be delayed, but the letter could also indicate that the US regulator does not expect the drug to ever reach the US market.
As a COX-2 medicine, parecoxib is part of the same class of drugs as Merck & Co’s controversial Vioxx, which has been linked to fatal cardiovascular problems.
In a statement, Pfizer said that it disagreed with the conclusions stated in the letter it received from the FDA, and that it plans to meet with the agency to discuss the agency’s concerns. The company went on to say that parecoxib is widely available worldwide, including in the European Union, mostly under the brand name Dynastat.
Pfizer further cited a review by the European Medicines Evaluation Agency (EMEA) earlier this year into the COX-2 class of pain medicines that concluded that, based on the overall safety data and with appropriate labeling, “the benefits continue to outweigh the risks.”