Celebrex approved for new arthritis indication
pharmafile | August 8, 2005 | News story | Sales and Marketing |Â Â Â
Celebrex has received US approval for a new indication as Pfizer looks to revive tumbling sales of its flagship COX- II inhibitor.
Pfizer's arthritis treatment's sixth US approval is for the treatment of ankylosing spondylitis, a form of arthritis of the spine, which affects around 400,000 Americans.
The approval coincides with changes to the labelling of Celebrex and older NSAID (non-steroidal anti-inflammatory) drugs in the wake of concerns surrounding the safety of these drugs.
Following a request from the FDA, Celebrex will now display a black box warning stating possible cardiovascular risks, such as an increased chance of heart attacks.
Its label will also display a new warning that Celebrex, like painkillers such as ibuprofen and naproxen, can cause gastrointestinal bleeding and serious ulcers.
Pfizer said its label will also recommend that Celebrex be prescribed at the lowest effective dose for the shortest duration.
Celebrex was one of Pfizer's biggest selling products but its sales have tumbled dramatically after Merck voluntarily withdrew its competing COX-II Vioxx last year because of safety concerns.
Celebrex's second quarter sales plunged 45% to around $400 million from last year but its market share of new prescriptions in the US has grown by about 10%.
Pfizer said that this growth is partly due to patients switching across to Celebrex from Bextra, the COX-II inhibitor Pfizer had intended to succeed Celebrex, but which like Vioxx has been withdrawn from the market because of safety concerns.
The company also said the FDA's approval for its latest indication demonstrated the regulator's confidence in Celebrex's safety, but is uncertain whether this confidence will be mirrored by doctors and patients.
Ankylosing spondylitis is as common as rheumatoid arthritis but unlike other forms of arthritis it usually strikes between the age of 17 and 35.
"With this new indication, Celebrex offers physicians a new treatment option for this difficult-to-treat patient population, said Dr Joseph Feczko, Pfizer's chief medical officer.
"The inflammation associated with ankylosing spondylitis can cause such severe pain that people who suffer from this condition – often young men – cannot perform even simple, everyday activities like walking and may have trouble attending school or work."
The condition is an indication for which Merck's own follow-up COX-II inhibitor Arcoxia is still awaiting approval.
Celebrex is already licensed for pain in osteoarthritis and adult rheumatoid arthritis, acute pain and menstrual pain, and for the treatment of adenomatous polyposis.
Related article:
Bextra suspended from European and US markets
Friday , April 08, 2005
