FDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.
FDA has approved the supplemental New Drug Application for tofacitinib citrate (Xeljanz, Pfizer) to include additional patient-reported outcomes data on the label.
"The patient-reported outcomes data show the impact that Xeljanz can have on the daily lives of patients with rheumatoid arthritis, based on physical, mental and emotional measures," said Steven Romano, senior vice president and the head of the medicines development group for Pfizer Specialty Care.
Last year, FDA approved tofacitinib 5 mg twice-daily for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The janus kinase inhibitor can be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs.
Pfizer said the new data from three phase 3 studies show improvement in patients receiving tofacitinib based on health-related outcome measures reported by patients, including vitality, role emotional, physical function, bodily pain, social function, mental health, role physical and general health.
Targeted Drug Combination Reveals New Activity in Brain Tumors
December 28th 2021A combination of two targeted cancer drugs showed unprecedented, “clinically meaningful” activity in patients with highly malignant brain tumors that carried a rare genetic mutation, according to a clinical trial report by investigators from Dana-Farber Cancer Institute.