Pfizer’s Xeljanz Approved by US FDA
Pfizer are celebrating today after US regulators approved their rheumatoid arthritis drug, Xeljanz, yesterday. The treatment is the first Janus kinase (JAK) inhibitor to be approved for rheumatoid arthritis.
The US Food and Drug Administration (FDA) have given the green light to Xeljanz (tofacitinib) 5mg twice-daily for the medication of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate.
The JAK inhibitor may be used as monotherapy or in combination with MTX or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
According to the Centers for Disease Control and Prevention, rheumatoid arthritis currently affects around 1.5 million Americans.
Xeljanz will be the first new oral DMARD for rheumatoid arthritis in over 10 years. The drug has been approved as a second-line medicine, which means that treatment with a biologic is not an essential prerequisite to taking the medication.
The approval comes with a risk assessment and mitigation strategy, and Pfizer have agreed to carry out post-marketing trials to gage long-term safety data and assess Xeljanz in children with polyarticular juvenile ideopathic arthritis.
Ian Read, Pfizer’s chief executive commented that Xeljanz is “an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease.” Onlookers believe that the drug is destined to become a blockbuster, aided by the fact that it is an oral medication.
In comparison, the biologics that have come on the market over the past ten years for rheumatoid arthritis, namely Amgen’s Enbrel, Abbott’s Humira and Johnson & Johnson’s Remicade, are all injectables. Furthermore, Pfizer have noted that Xeljanz will cost less than these three well-established treatments.
Pfizer shares increased by 1.2% at $25.01 after the approval was announced.