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FDA considering promising new drugs for arthritis
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| A new arthritis drug may be approved by the FDA | |
Web posted at: 9:42 a.m. EDT (1342 GMT)
BIRMINGHAM, Alabama (CNN) -- The U.S. Food and Drug Administration is considering whether to approve a new arthritis drug that researchers say could offer relief to millions of people who suffer from rheumatoid arthritis.
Enbrel is the first in a new class of drugs, and is the first of several that with FDA approval could hit pharmacy shelves within a year.
Both researchers and patients say enbrel offers relief without the side effects that accompany other 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," explained Dr. Larry Moreland, a researcher at the university.
Enbrel doesn't cure
Enbrel inhibits tumor necrosis factor, or TNF, which is a protein that causes the inflammation that leads to joint destruction. 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.
Experts warn that enbrel is not a cure, and 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 Dr. Doyt Conn, of the Arthritis Foundation. "So, it's certainly not a cure, it's a disease modifier, and it's going to be very helpful."
Several other 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.
Arthritis is the number one cause of disability in the United States. Some 2.1 million Americans, mostly women, suffer from rheumatoid arthritis.
Correspondent Rhonda Rowland contributed to this report.
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