The FDA has accepted for review the supplemental New Drug Application (sNDA) for tofacitinib citrate (Xeljanz, Pfizer) 5mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A second sNDA was also accepted for review for tofacitinib citrate (Xeljanz XR, Pfizer) extended release 11mg once daily use in patients with PsA.
Pfizer submitted its sNDA based on data from the Phase 3 Oral Psoriatic Arthritis Trials (OPAL) clinical development program. The program consisted of 2 pivotal trials and a long-term extension study. It evaluated the safety and efficacy of tofacitinib citrate in patients with active PsA who had failed prior PsA treatments. The study focused on conventional synthetic disease-modifying antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations. It was the first PsA study exclusively focused on a TNFi-IR population.
According to the findings, both studies met the primary efficacy endpoints, and showed a statistically significant improvement with tofacitinib citrate 5 mg and 10 mg BID compared to treatment with placebo at 3 months. The researchers used the American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score to measure patient responses. The overall safety findings were consistent with those observed in the broader rheumatology clinical development program for tofacitinib citrate. In both studies, researchers found that adverse events were more frequent with tofacitinib citrate 5mg and 10mg BID compared to placebo.
The FDA has provided an anticipated Prescription Drug User Fee Act action date in December 2017 for the sNDAs. Tofacitinib citrate is not approved for the treatment of psoriatic arthritis.
The FDA has accepted for review the supplemental New Drug Application (sNDA) for tofacitinib citrate (Xeljanz, Pfizer) 5mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A second sNDA was also accepted for review for tofacitinib citrate (Xeljanz XR, Pfizer) extended release 11mg once daily use in patients with PsA.
Pfizer submitted its sNDA based on data from the Phase 3 Oral Psoriatic Arthritis Trials (OPAL) clinical development program. The program consisted of 2 pivotal trials and a long-term extension study. It evaluated the safety and efficacy of tofacitinib citrate in patients with active PsA who had failed prior PsA treatments. The study focused on conventional synthetic disease-modifying antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations. It was the first PsA study exclusively focused on a TNFi-IR population.
According to the findings, both studies met the primary efficacy endpoints, and showed a statistically significant improvement with tofacitinib citrate 5 mg and 10 mg BID compared to treatment with placebo at 3 months. The researchers used the American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score to measure patient responses. The overall safety findings were consistent with those observed in the broader rheumatology clinical development program for tofacitinib citrate. In both studies, researchers found that adverse events were more frequent with tofacitinib citrate 5mg and 10mg BID compared to placebo.
The FDA has provided an anticipated Prescription Drug User Fee Act action date in December 2017 for the sNDAs. Tofacitinib citrate is not approved for the treatment of psoriatic arthritis.
The FDA has accepted for review the supplemental New Drug Application (sNDA) for tofacitinib citrate (Xeljanz, Pfizer) 5mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A second sNDA was also accepted for review for tofacitinib citrate (Xeljanz XR, Pfizer) extended release 11mg once daily use in patients with PsA.
Pfizer submitted its sNDA based on data from the Phase 3 Oral Psoriatic Arthritis Trials (OPAL) clinical development program. The program consisted of 2 pivotal trials and a long-term extension study. It evaluated the safety and efficacy of tofacitinib citrate in patients with active PsA who had failed prior PsA treatments. The study focused on conventional synthetic disease-modifying antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations. It was the first PsA study exclusively focused on a TNFi-IR population.
According to the findings, both studies met the primary efficacy endpoints, and showed a statistically significant improvement with tofacitinib citrate 5 mg and 10 mg BID compared to treatment with placebo at 3 months. The researchers used the American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score to measure patient responses. The overall safety findings were consistent with those observed in the broader rheumatology clinical development program for tofacitinib citrate. In both studies, researchers found that adverse events were more frequent with tofacitinib citrate 5mg and 10mg BID compared to placebo.
The FDA has provided an anticipated Prescription Drug User Fee Act action date in December 2017 for the sNDAs. Tofacitinib citrate is not approved for the treatment of psoriatic arthritis.
