11/27 11:02 Reuters: FDA advisers to consider first of new pain drugs
By Alicia Ault
WASHINGTON, Nov 27 (Reuters) - A drug for treatment of arthritis pain, the
first of a widely anticipated group of new pain-relieving drugs, goes before a
Food and Drug Administration (FDA) advisory panel next week.
The drug, Celebrex, made by Monsanto Co. <MTC.N> unit G.D. Searle, is in
a class of drugs known as COX-2 inhibitors that should be better suited for
long-term use because they do not attack the stomach lining like other
nonsteroidal anti-inflammatories (NSAIDS) such as aspirin, ibuprofen or
naproxen.
An estimated 16 million Americans suffer from osteoarthritis, the degenerative
disease of the joints that affects virtually everyone over the age of 75.
At the advisory meeting on Tuesday, Celebrex might also be recommended for
the early stages of rheumatoid arthritis, an autoimmune disease in which the
body attacks its own joint tissues that affects about 1 percent of the population.
The FDA is not bound by the advice of its advisory committees but usually
follows their recommendations.
The market for such drugs looks huge as the population ages. "I think $3
(billion) to $4 billion a year is almost a given," independent drug industry analyst
Hemant Shah told Reuters.
Merck and Co. Inc. <MRK.N> has submitted a similar drug called Vioxx for
FDA approval. Searle plans to co-market Celebrex with Pfizer Inc. <PFE.N>
COX-2 drugs hold the potential to curb hospitalizations and deaths in people at
highest risk for gastrointestinal problems, Lee Simon, a rheumatologist and
professor of medicine at Harvard Medical School, said.
Complications such as ulcers and stomach perforations cause 7,000 to 20,000
deaths a year, according to Stanford University researchers. Sold by
prescription and over the counter, NSAIDS are taken by at least 13 million
Americans for arthritis.
"These new drugs are a light-year development forward from a safety point of
view," Simon, who has been an investigator for several Celebrex studies,
added.
Simon said COX-2s will also be important for patients who need to have
surgery. Often they have to stop taking traditional anti-inflammatory drugs up to
two weeks prior or just after surgery because they can cause bleeding.
COX-2 inhibitors affect cyclooxygenase-2, an enzyme made by the body in
response to pain or trauma. When COX-2 is released, it triggers the production
of prostaglandin hormones that cause swelling and inflammation.
The drugs do not block COX-2 release, but do reduce the amount of
prostaglandin being made.
But detailed clinical data on Celebrex has not yet been published, and some
researchers still have concerns about COX-2 drugs. "I will predict these won't
be safer in patients with intrinsic kidney disease," Harvard's Simon said.
At an FDA meeting on COX-2 drugs in March, FDA advisers said they
wanted more data on the drugs' effects on the kidney, and also on bone,
fertility, and mental performance.
But drug industry analysts think Celebrex is destined for approval. "The
downside is going to be price," Hambrecht & Quist analyst Alex Zisson said.
With treatment expected to cost $2-$4 a day, Zisson thinks first year sales may
hit $300-400 million, but final estimates will depend on whether health insurers
decide on strict limits for who gets the new drugs, according to Zisson.
The FDA advisers will also have a say in which patients will best benefit. "This
shouldn't be used for a headache, this should be used in patients on long-term
therapy for arthritis," Simon said. |
