FOCUS-U.S. experts back new arthritis drug
Tuesday December 1, 7:08 pm Eastern Time
(Panel backs new drug for osteoarthritis, rheumatoid arthritis)
By Maggie Fox, Health and Science Correspondent
SILVER SPRING, Md., Dec 1 (Reuters) - A U.S. Food and Drug Administration advisory panel
voted on Tuesday to recommend approval of the first of a new class of drugs for osteoarthritis and rheumatoid arthritis.
Celebrex, made by Monsanto Corp. (NYSE:MTC - news) unit G.D. Searle, would be the first on the U.S. market in a new class known as COX-2 inhibitors. They are designed to work as well as other analgesics such as aspirin, ibuprofen and naproxen, known as as non-steroidal anti-inflammatory drugs (NSAIDS), but without potentially fatal side effects.
The panel was still discussing whether the drug, known generically as celecoxib, should carry a label warning of safety considerations and whether to approve it for managing pain such as that suffered after an operation.
Analysts say the market is huge, with potential sales of $1 billion in the first year in the United States alone if Celebrex is launched next year as the company hopes. The FDA has expedited consideration of the drug and usually acts on the advice of its panels.
Rheumatoid arthritis is an auto-immune disease caused when the body's immune system mistakenly turns against the joints. Osteoarthritis is the ''wear and tear'' form of arthritis. Both cause painful and
swollen joints.
Patients must often take drugs for years because neither disease has a cure, so safer drugs are highly
desirable.
Osteoarthritis and rheumatoid arthritis are chronic diseases for which there is no cure, so a safer drug that patients could take long-term would be highly desirable.
Searle ran into a hiccup during the panel meeting when FDA experts questioned some of its claims about the drug's effectiveness and side-effects.
One said the studies did not clearly show Celebrex was better than no treatment at all in managing pain such as post-operative pain.
''We believe that celecoxib at this time has not yet met the requirements for critical management of acute pain,'' Mordechai Averbuch, a medical officer at the FDA, told the meeting.
Averbuch said the FDA usually requires two separate models that show an analgesic can reduce pain. He said the drug was not superior to placebo in some studies, including two studies of knee pain in osteoarthritis patients.
And Dr. Lawrence Goldkind, another FDA medical officer, said the company had not fully addressed questions about whether Celebrex caused no more ulcers that treatment with a dummy pill.
Searle said it was not worried.
''For us the most important piece of this was the osteoarthritis and rheumatoid arthritis,'' Scarlett Lee Foster, a spokeswoman for Searle, said afterward. ''We certainly will be discussing with the FDA the general management of pain.''
NSAIDS work against an enzyme known as cyclooxygenase, COX for short, which triggers pain and inflammation. There are two versions -- COX-1 and COX-2. NSAIDS work against both kinds.
Research has shown that suppressing COX-1 may lead to the stomach damage caused by NSAIDS.
Makers of the COX-2 inhibitors say it is produced mostly in response to trauma, and drugs that affect only COX-2 should be more safe and effective than NSAIDS.
Of 13 million Americans who take traditional drugs to treat arthritis pain, 100,000 are hospitalized each year from complications such as ulcers and bleeding. An estimated 10,000 to 20,000 die.
SmithKline Beecham (quote from Yahoo! UK & Ireland: SB.L) and American Home Products unit Wyeth-Ayerst (NYSE:AHP - news) already sell COX-2 inhibitors that are preferential -- they do not completely block the enzyme.
Dr. Robert Palmer of SmithKline told the panel the differences between COX-1 and COX-2 may not be as clear as Searle says they are.
''While this may be an excellent product, we just don't know yet all we need to know about the function of these enzymes,'' he said.
But, he added: ''These considerations are not meant to imply that specific COX-2 inhibitors are not good drugs. They will be excellent drugs.''
Tuesday's decision is crucial to drug makers seeking a piece of the $5 billion to $12 billion market for over-the-counter and prescription NSAIDS.
The stakes were clear at the meeting.
Aspirin manufacturers asked the FDA to take care in warning about any dangers of NSAIDs in approving the drug, so as not to hurt the over-the-counter analgesic market.
And Dr. Sidney Wolfe of the consumer group Public Interest said he was worried the COX-2 inhibitors would be marketed as drugs that are much safer than NSAIDs without proof this is so. He called for strict labeling requirements, saying the drugs ''offer not only a new method of action but a new method of toxicity''.
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