Preliminary results from an ongoing study show that bimekizumab improves joint and skin symptoms in patients with psoriatic arthritis…
Etanercept’s New Autoinjection System; Plus FDA Approves Ixekizumab for Active PsA
In the U.S., a new formulation and an ergonomic delivery system for single doses of etanercept are now available for RA patients…
Rheumatology Drug Updates: Efficacy Studied Following Accelerated Drug Approvals; Plus Secukinumab Meets Benchmark for Psoriasis
Medications for serious or life-threatening conditions may receive accelerated approval from the U.S. Food and Drug Administration (FDA) by showing an effect on surrogate measures that are reasonably likely to predict a treatment’s clinical benefit. Post-approval confirmatory drug trials are then required to determine whether or not these effects translate into clinical improvements. In recent…
Secukinumab Meets 5-Year Benchmark for Psoriasis
In an extension study, nearly half the patients with plaque psoriasis taking secukinumab maintained skin clearance for the five years of the study…
Abatacept Approved for Psoriatic Arthritis in Adults; Sirukumab Approval Stalls
Abatacept Approved for Adult PsA On June 30, the U.S. Food and Drug Administration (FDA) approved abatacept (Orencia) to treat adults with active psoriatic arthritis (PsA).1 Abatacept is available as both an intravenous formulation and a subcutaneous injection.2 The approval was based on results of two randomized, double-blind, placebo-controlled trials, PsA-I and PsA-II, during which…
FDA Committee Recommends Tofacitinib Approval
The FDA Arthritis Advisory Committee voted 10 to 1 to recommend approval of tofacitinib to treat psoriatic arthritis…
Beyond Awareness: August Is Psoriasis Action Month
This month, the National Psoriasis Foundation is urging patients and rheumatologists to take charge of psoriatic disease by setting ambitious treatment goals to achieve better health outcomes…
Abatacept Approved for Adult PsA
The FDA has approved abatacept to treat adults with active psoriatic arthritis. In clinical trials, the treatment has proved effective in both intravenous and subcutaneous forms…
FDA Responds to New Drug Application for Baricitinib
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
Ixekizumab Eases Psoriatic Arthritis when TNF Inhibitor Fails
NEW YORK (Reuters Health)—The selective interleukin-17A inhibitor ixekizumab improved signs and symptoms of active psoriatic arthritis (PsA) in patients who had failed prior biologic therapy in the phase 3 SPIRIT-P2 trial. The SPIRIT-P2 trial joins the earlier phase 3 SPIRIT-P1 trial, which showed that ixekizumab was safe and effective in PsA patients not previously treated…
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