Drug Approvals Keep Coming for Pfizer

Pfizer Inc. (NYSE:PFE), it seems, is on a roll. The pharmaceutical giant on Monday announced the approval of Xeljanz (tofacitinib citrate), its rheumatoid arthritis drug, in additional countries around the world — including Switzerland, the first European country to receive approval for the drug.

The news comes less than a week after the drugmaker won extended European approval for its popular Prevenar 13 antibacterial vaccine.

Xeljanz can be used alone or in combination with other drugs for moderate to severe rheumatoid arthritis in adults who have an inadequate response or intolerance to methotrexate, another rheumatoid arthritis drug, Pfizer said.

The 5-mg dose previously won approval from regulators in the United States, Argentina, Japan, Kuwait, and the United Arab Emirates, with Russia — where the drug will be called Jaquinus – approving both the 5- and 10-mg versions.

Xeljanz is the first approved rheumatoid arthritis treatment in a new medicine class called Janus kinase inhibitors, according to the drugmaker, and regulatory applications for the treatment are still under review in more than 30 other countries.

“More than 23 million people worldwide are living with rheumatoid arthritis and there remains an unmet need for additional treatments, with up to one-third of [rheumatoid arthritis] patients not adequately responding and about half who stop responding to any particular [disease-modifying antirheumatic drugs] within five years,” Geno Germano, Pfizer’s specialty care and oncology president and general manager, said in a press release. “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.”

Rheumatoid arthritis is an autoimmune disorder that affects the lining of the joints and causes painful swelling that can lead to bone erosion and joint deformity, according to the Mayo Clinic. Treatment for the chronic inflammatory disorder focuses on on controlling symptoms and preventing joint damage.

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