Unichem Laboratories Ltd.
The Food and Drug Administration approved Xeljanz (Tofacitinib) for the treatment of moderate to severe rheumatoid arthritis patients who are treatment-unresponsive or intolerant to methotrexate. Xelijanz is to be marketed by Pfizer Pharmaceuticals. Xeljanz is a twice-daily drug that inhibits inflammatory pathway mediators such as Janus kinases in pathophysiology of rheumatoid arthritis.
According to Dr. Badrul Chowdhury, who directs the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research, Xeljanz paves a way to new therapeutic option for methotrexate-resistant, rheumatoid arthritis patients.
Seven clinical trials were conducted in moderate to severe RA patients to ascertain the safety and benefits of Xeljanz. The Xeljanz-treated group in all the clinical trials reported improvement in symptoms and physical activity. However, no such improvements were reported in placebo groups.
Xeljanz is to be marketed with a boxed warning that warns serious, opportunistic infections in immunocompromised individuals due to iatrogenic immunosuppression. According to warning, Xeljanz can also cause anomalies in blood counts, lipid profile and LFTs. Xeljanz has been approved by USFDA based on Risk Evaluation and Mitigation Strategy (REMS) that includes medication guide and safety information for patients and healthcare providers.
The FDA directed the manufacturer to conduct post-marketing clinical trials on twice daily Xeljanz doses that are to be compared with a control group of another, approved treatment. The Pfizer is yet to study the safety and efficacy profiles of Xeljanz on malignancies, systemic sepsis and CVDs.
The commonly reported adverse events are GI disturbances with diarrhoea, nasopharyngeal infections with inflammation and headache.
Sandoz Pvt. Ltd. (Novartis India)