A survey conducted by Datamonitor Healthcare has found that Xeljanz, a drug produced by Pfizer to treat rheumatoid arthritis (RA), would likely still be prescribed by doctors to their patients despite a negative review by a leading medicinal committee.
The Committee for Medicinal Products for Human Use (CHMP) gave a negative review of the drug, basing their decision on safety issues involving side effects that included ‘certain cancers, gastro-intestinal perforations liver damage and problems with increased lipid (fat) levels in the blood’.
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According to the survey, around 85% of rheumatologists were still certain that Xeljanz could provide their patients with the benefits that it claims to have.
Datamonitor Healthcare analyst Rachel Chizkov said: "Despite the CHMP’s negative opinion regarding Xeljanz, rheumatologists in the EU are still enthusiastic about the drug and its potential to treat moderate to severe rheumatoid arthritis."
Pfizer Specialty Care senior vice-president Dr Steven Romano said that the company was disappointed in the ‘outcome of the re-examination process’.
"A narrow majority of the CHMP felt there is too limited experience in the patient population to fully characterise the profile of XELJANZ and the Committee did not recommend approval at this time," he said.
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By GlobalDataMost of the survey respondents, which comprised of key leaders in the field of rheumatology, believed that Xeljanz is ‘well-tolerated and safe, with short-term efficacy’.
However, many also felt that Pfizer should conduct at least a five-year trial to make sure that the long-term effects of Xeljanz actually led to a significant reduction in the symptoms from RA.
Dr Romano maintained that Pfizer still felt that Xeljanz’s ‘benefit:risk profile’ is a favourable one. He confirmed that the company would ‘remain committed to working with the EMA to make XELJANZ available to appropriate patients in Europe’.
