FDA Panel Recommends New Arthritis Drug Approval

By Raoul Railey
20:09, July 30th 2008
38 votes
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FDA Panel Recommends New Arthritis Drug Approval

An FDA panel voted Tuesday 10 to 1 for the approval of a new drug that fights against rheumatoid arthritis. Even thought the Food and Drug Administration agency doesn't necessarily have to follow the panel's recommendation, it usually does, so doctors might be able to prescribe Actemra, the new drug, in the near future.

Rheumatoid arthritis is an autoimmune disease in which the body turns against its own joints and starts attacking them. In most cases, rheumatoid arthritis, also called RA, leads to disabilities and, in some severe and untreated cases, even to an early death. Several drugs against the disease are already on the market, but there are patients that see no improvement after being treated with them.

Actemra, which was created at the Roche laboratories, uses a different approach than the other drugs to fight against RA. The Roche drug inhibits the interaction between the IL-6 protein, which, if produced in excess can cause inflammations, and the cells. The other drugs that are already used to treat RA are blocking the tumor necrosis factor protein.

While studies have shown that Actemra is efficient against RA, its potential side effects have made experts wonder whether they should approve the drug or not. It was discovered that in some cases Actemra raises the level of bad cholesterol and sometimes attacks the liver as well.

What made the panel recommend the drug was Amectra's different approach at fighting RA, as well as the possibility that people for whom other drugs don't provide any improvements may find the new drug more efficient for their condition.



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