Monday, May 07, 2012

FDA Concerns Pertaining to The Risks, The Benefits & The Appropriateness of Tofacitinib to Treat Rheumatoid Arthritis

Hmmmm!! They ask questions???  I wonder who died.

"The FDA said tofacitinib might be associated with an increased risk of cancer such as lymphoma, and that it increased the risk of serious infections, some of which were fatal. The agency also said it couldn't make "definitive conclusions" regarding the drug's effectiveness on a measure that looked at disease progression."
The poor people that took the risk and didn't benefit?

Well, we will see on Wednesday if they make the logical decision based on the numbers they see showing disease advancement or decline
 

FDA:Questions Safety, Effectiveness Of Proposed Pfizer Arthritis Drug
 
Published May 07, 2012
 
Dow Jones Newswires
 
WASHINGTON –  The Food and Drug Administration questioned the safety and effectiveness of a proposed Pfizer Inc. (PFE) drug for rheumatoid arthritis.
The drug, tofacitinib, is designed to treat the disease in a different manner than currently approved therapies. The product will be reviewed on Wednesday by the FDA's arthritis drugs advisory committee.
The FDA said tofacitinib might be associated with an increased risk of cancer such as lymphoma, and that it increased the risk of serious infections, some of which were fatal. The agency also said it couldn't make "definitive conclusions" regarding the drug's effectiveness on a measure that looked at disease progression.
The FDA released a review of the product Monday in preparation for Wednesday's meeting. Tofacitinib works to inhibit a cell-signaling mechanism referred to as JAK and is a key drug in Pfizer's pipeline.
The company studied the drug in about 4,800 patients. Five studies were submitted to the FDA in support of the drug's approval. Most of the patients in the studies hadn't responded to initial therapy with a drug called methotrexate. One study focused on patients who had an inadequate response to newer drugs called TNF-inhibitors such as Remicade or Humira, which work to block a substance in the body called tumor necrosis factor that can cause inflammation and lead to immune-system diseases, such as rheumatoid arthritis, Crohn's disease and ulcerative colitis.
Pfizer has said it believes the side-effect profile of tofacitinib is similar to other treatments on the market. The labels for TNF-blockers warn of serious and sometimes fatal infections and a possible increased risk of getting certain types of cancer.
The FDA's panel, which is made up of non-FDA medical experts, will be asked to vote on whether it thinks the drug should be approved. The FDA isn't required to follow the advice of its panels but usually does.
Rheumatoid arthritis is a chronic inflammatory disorder that usually affects small joints in the hands and feet.
Copyright © 2012 Dow Jones Newswires


Read more: http://www.foxbusiness.com/news/2012/05/07/fdaquestions-safety-effectiveness-proposed-pfizer-arthritis-drug/#ixzz1uBr92NAR

2 comments:

  1. The hidden surprise in tofacitinib is that since it is a JAK inhibitor, it is effective against two disorders caused by HTLV: HAM and ATL. Once the drug is approved, 25 million HTLV sufferers will ask their doctors for tofacitinib, in order to treat HAM (which leads to being in a wheelchair) and ATL (which leads to death by a rapidly fatal leukemia). Other JAK inhibitors include AG490.

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  2. interesting. I ddn't know much about those conditions. I found this about human T-cell Lymphotropic Virus. It's a short summary of the viruses.

    4 HTLVs are well established. HTLV-1 and HTLV-2 are both involved in actively spreading epidemics, affecting 15-20 million people worldwide.[4] HTLV-1 is the more clinically significant of the two, as it has been proven to be the etiologic agent of multiple disorders. At least 500,000 of the individuals infected with HTLV-1 eventually develop an often rapidly fatal leukemia, while others will develop a debilitative myelopathy, and yet others will experience uveitis, infectious dermatitis, or another inflammatory disorder. HTLV-2 is associated with milder neurologic disorders and chronic pulmonary infections. The novel HTLV-3 and HTLV-4 have been isolated only in a few cases; no specific illnesses have yet been associated with these viruses.

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