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FDA panel recommends arthritis drug approval
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| A new arthritis drug may be approved by the FDA | |
Web posted at: 12:08 a.m. EDT (0408 GMT)
WASHINGTON (CNN) -- An advisory panel to the U.S. Food and Drug Administration recommended Wednesday that Enbrel, a promising new drug to fight rheumatoid arthritis, be approved for use.
If the FDA goes along with the recommendation of the advisory panel, which it usually does, Enbrel could offer a new era of relief for people suffering from rheumatoid arthritis, which affects 2.1 million Americans, mostly women. It is the No. 1 cause of disability in the United States.
Dr. Doyt Conn of the Arthritis Foundation says that while Enbrel is "certainly not a cure, it's a disease modifier, and it's going to be very helpful."
Enbrel, which could hit pharmacy shelves within a year, is the first in a new class of drugs that inhibit the chronic inflammation of joints that ultimately leads to permanent damage. Both researchers and patients who have tested the drug say it offers relief without the side effects that accompany other arthritis drug therapies.
"A miracle had happened in my body, and I was normal. I felt wonderful. I had no morning stiffness, no pain, no swelling," said Gloria Baswell, who participated in a study of the drug at the University of Alabama at Birmingham.
Before taking part in the study, Baswell said she had been in constant pain for two years. She now crochets.
She is among the more than 75 percent of study participants whose arthritis symptoms improved with the use of Enbrel.
"Enbrel is a breakthrough drug in that it's the first drug that specifically targets the knowing process that occurs in the joints," said Dr. Larry Moreland, a UAB researcher.
Enbrel inhibits tumor necrosis factor, or TNF, a protein that causes the inflammation that destroys joints. The drug works by binding with, or hooking onto, the TNF protein before it can cause joint damage, meaning it essentially stops the disease process.
While the results have been promising, Moreland cautioned, "There is a subset of patients who have not had significant improvements."
"We know from the studies that have been done that after (the patient's use of Enbrel) has stopped, the disease can come back," said Conn.
Several similar arthritis drugs are also expected to be on the market within a year.
The FDA is to consider another TNF-blocker, called Remicade, before the end of the year. And last week, the agency approved Arava, a drug that works similar to methotrexate, which is currently widely used in the treatment of arthritis.
A gentler type of aspirin or painkiller, called Cox-2 inhibitors, is also expected to hit the market soon.
Correspondent Rhonda Rowland contributed to this report.
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