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Carol Eustice

Tofacitinib Recommended for FDA Approval to Treat Rheumatoid Arthritis

By May 9, 2012

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The Arthritis Advisory Committee to the U.S. FDA has voted 8-2 to recommend approval of tofacitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis. If approved, tofacitinib would be the first new oral disease-modifying anti-rheumatic drug (DMARD) for rheumatoid arthritis in more than 10 years and the first oral biologic drug belonging to a new class of drugs known as JAK (Janus kinase) inhibitors. The FDA is expected to make their decision on Pfizer's new drug for rheumatoid arthritis in August 2012.

Unlike other currently existing biologic drugs that target extracellular entities, such as proinflammatory cytokines, tofacitinib targets intracellular pathways that operate as hubs in the inflammatory cytokine network, according to Pfizer. Tofacitinib has been studied in about 4,800 patients. There have been five Phase III trials and two ongoing, long-term extension studies in numerous countries around the world. The drug was recommended for approval despite some concern over side effects including lymphoma, infection, and elevated cholesterol levels. Proponents believe there is a need for more treatment options, especially for rheumatoid arthritis patients who have not responded to other treatments or for those who develop antibodies to current biologic treatments and have to discontinue use.

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August 22, 2012 at 3:01 pm
(1) TonyDewitt says:

The FDA has set a date of November 21, 2012 for approval of tofacitinib. 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).

November 8, 2012 at 12:31 pm
(2) T D says:

Xeljanz (tofacitinib) has been approved on November 7th, 2012 – the hidden surprise is that it is effective against two disorders caused by HTLV: HAM and ATL. Since there are WAY more HTLV sufferers than arthritis sufferers, this drug will sell well because HTLV sufferers have no treatment for their suffering thus far.

November 10, 2012 at 5:26 pm
(3) Adelia Smith says:

How expensive will this treatment be? I have been on Enbrel for 7 years. It is way too expensive,over $2000 per month.

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