EMA confirms negative opinion on Pfizer’s Xeljanz

July 26 2013 | By Márcio Barra

Pfizer received a second negative evaluation from the EMA’s CHMP regarding their rheumatoid arthritis treatment Xeljanz (tofacitinib citrate), confirming its April 25, 2013 opinion to recommend against the approval of Xeljanz. This is the second time that the CHMP says no to Pfizer’s drug.

After a re-examination of the application as requested by Pfizer, the CHMP remained on the opinion that Xeljanz does not demonstrate a favorable benefit – risk profile, and thus a Market Authorization was recommended against again.

Like the first evaluation, the CHMP recognized the efficacy of Xeljanz in the treatment of rheumatoid arthritis from the data provided from the five main clinical trials, although there were doubts concerning the efficacy, namely in the consistent reduction in disease activity and structural damage to joints. Pfizer proposed to remove claims of an effect on structural damage from the indication. However, concerns on the drug’s safety, including serious infections, which are related to the immunosuppressant action of the medicine, sealed the deal for the CHMP. Other safety concerns included certain cancers, gastro-intestinal perforations (holes in the wall of the gut), liver damage and problems with increased lipid (fat) levels in the blood.

In a press release issued by the company, Pfizer “is currently evaluating the feedback from the CHMP and will determine next steps to resubmit a MAA to the EMA”

Steven Romano, head of the medicines development group for Pfizer Specialty Care division claimed that “a narrow majority of the CHMP felt there is too limited experience in the patient population to fully characterize the profile of Xeljanz”, expressing disappointment with the Committee’s decision.

He added that the clinical experience with Xeljanz to date, “which includes data from approximately 5,000 patients treated for RA, demonstrates a consistent efficacy and safety profile across a range of patient types”. He concluded by saying that “we believe that the benefit/risk profile of Xeljanz is favourable, and we remain committed to working with the EMA”.

Xelnjaz was launched in the US this past November following a positive approval by the FDA. FDA’s approval made tofacitinib the first oral antirheumatic drug in more than 10 years. Switzerland’s SwissMedic approved Xeljanz last week for sale, making Switzerland the first European country to approve Xeljanz.

Tofacitinib, the active ingredient of Xeljanz, is an inhibitor of the janus kinase (JAK) family, particularly JAK 3. JAK are enzymes that play a crucial role in the process of inflammation and damage of the joints.By blocking the enzymes, the drug reduces the inflammation and other symptoms of rheumatoid arthritis.

Read EMA’s release

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