Pfizer's rheumatoid arthritis treatment, tofacitinib, has obtained approval in several additional countries globally, including Switzerland, Argentina, Kuwait, UAE and Russia for patients with inadequate response to current therapies.
The Swiss agency for therapeutic products, Swissmedic, cleared tofacitinib 5mg and 10mg twice-daily (BID) as monotherapy or combination therapy along with a disease modifying non-biologic antirheumatic agent (DMARD) such as methotrexate (MTX).
Tofacitinib 5mg BID with brand name Xeljanz obtained clearance in Argentina, Kuwait and the UAE, and tofacitinib 5mg and 10mg BID has been cleared in Russia, where the brand name will be Jaquinus.
Pfizer specialty care and oncology president and general manager Geno Germano said Xeljanz has a novel mechanism of action for the treatment of moderate-to-severe RA.
"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," Germano added.
Earlier Xeljanz 5mg BID, belonging to a new class of medicines known as Janus kinase (JAK) inhibitors, was approved in the US and Japan for the treatment of moderate-to-severe active RA.
The medication is already launched in the US and will be jointly promoted by Pfizer and Takeda Pharmaceutical Company in Japan.
Data from the global, multi-study clinical development program for Xeljanz, which included approximately 5,000 patients in over 40 countries, supported marketing authorizations for Xeljanz.
