Pfizer’s ambitions for oral rheumatoid arthritis (RA) drug tofacitinib continue to grow after the drug was approved in five more countries.
The pharma company will now be able to market the Janus kinase (JAK) inhibitor for use in patients in Switzerland, Argentina, Kuwait and the United Arab Emirates under the name Xeljanz and in Russia under the name Jaquinus.
This adds to current approvals in the US and Japan for the use of Xeljanz in the treatment of moderate-to-severe active RA, and Pfizer has already announced plans to improve its manufacturing capabilities in Ireland in order to cope with growing demand for the tipped blockbuster.
These latest approvals are especially significant considering Pfizer’s struggle to win approval for the drug in Europe, where in April this year the European Medicines Agency (EMA) refused to recommend Xeljanz as clinical trials did not demonstrate a favourable risk-to-benefit profile.
Pfizer said it is seeking a re-examination of this opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and is working with CHMP on possible next steps.
The CHMP’s main concerns were to do with the link between Xeljanz and an increased risk of adverse events, such as opportunistic infections, tuberculosis, cancers and lymphoma.
The US Food and Drug Administration (FDA) also took these concerns into consideration but deemed that Pfizer could market Xeljanz if it carried a boxed warning containing these safety risks.
The drug was launched in the US in November 2012, and analysts will be eagerly waiting an update on its performance in Pfizer’s upcoming half-year report for 2013.
In addition, the company said Xeljanz is likely to be commercially available in Japan this month where it will be co-promoted by Pfizer and Takeda.
“Xeljanz has a novel mechanism of action for the treatment of moderate-to-severe RA,” said Geno Germano, president and general manager, speciality care and oncology, Pfizer, noting that the drug is the first JAK inhibitor cleared for marketing.
“With these approvals, we believe Xeljanz has the potential to change the way rheumatologists treat this chronic, and potentially disabling, disease, and we are proud to offer patients and physicians an additional treatment option.”