Pfizer would have breathed a sigh of relief yesterday, after hearing that advisors to the US Food and Drug Administration have recommended approval of its COX-2 inhibitor Celebrex (celecoxib) for juvenile rheumatoid arthritis.
It was touch and go for the product, as pre-hearing briefings revealed agency staff were concerned about giving the green light to a COX-2 agent, given that two drugs in the same class - Merck & Co's Vioxx (rofecoxib) and Pfizer's own Bextra (valdecoxib) - have been withdrawn over links to cardiovascular problems.
That said, in recent months the COX-2 class has experienced something of a recovery, and Pfizer argues that Celebrex has been proved to be as effective as the non-steroidal anti-inflammatory class naproxen in treating juvenile rheumatoid arthritis in trials. The company maintains that the benefit/risk balance of the drug is favourable to approval, and says it will be "supportive" of any labelling changes the FDA may request.
And the FDA panel seemed to agree, voting that the benefit of Celebrex indeed outweighs the risks, and overlooking previous concerns over the lack of research into the cardiovascular risks of long-term use of the drug in children.
Celebrex is currently approved for six indications in the USA, including osteoarthritis, rheumatoid arthritis, and management of acute pain in adults, and carries a black-box warning detailing possible cardiovascular risks and gastrointestinal problems.
Nevertheless, the drug looks almost certain to top the $2 billion barrier this year, a threshold which was billed at the start of the year as an ambitious target for a drug that pulled in $3.3 billion in 2004.