Due to manufacturing deficiencies found during a routine inspection by the FDA, approval of sarilumab for treating RA has slowed until facility issues are resolved…
Rheumatology Drug Updates: Biosimilars Receive Positive News & More
On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 On Jan. 16, 2016, EMA granted marketing authorization in the European Union for Benepali to be used to treat rheumatoid arthritis (RA), psoriatic…
Apremilast Proves Effective for PsA with Skin Involvement
A recent Phase 3 clinical trial found apremilast safe and effective for treating patients with active psoriatic arthritis and skin symptoms who found conventional and biologic DMARDs ineffective…
Apremilast Effective for Psoriatic Arthritis
NEW YORK (Reuters Health)—Apremilast improves clinical outcomes in patients with psoriatic arthritis and active psoriasis, according to results from the PALACE 3 randomized controlled trial. Apremilast, a phosphodiesterase 4 (PDE4) inhibitor, showed efficacy against psoriatic arthritis in the PALACE 1 trial. Dr. Christopher J. Edwards from University Hospital Southampton in the U.K. and colleagues evaluated…
One-Year Data Shows Apremilast Effective in Severe Scalp, Nail Psoriasis
NEW YORK (Reuters Health)—Apremilast is effective in patients with difficult to treat psoriasis of the scalp and nails, according to long-term results of two phase 3 trials. Investigators had previously reported 16-week data from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2 trials. The new report includes…
Rheumatology Drug Updates, Trials, Safety Data
Information on oral anticoagulant apixaban, apremilast for active psoriatic arthritis, hyaluronic acid and methotrexate injections, and drug safety updates rheumatologists need to know
Approval Expected for Apremilast
New drug shows promise in treating psoriatic arthritis, ankylosing spondylitis & psoriasis