The FDA approved secukinumab (Cosentyx) this past week for the treatment of adults with active ankylosing spondylitis and active psoriatic arthritis. These two new approvals are based on the safety and efficacy outcomes from four placebo-controlled Phase 3 trials in more than 1,500 adults with AS or PsA…
Sarilumab Is Effective for RA, Pregabalin Fails to Meet Study Endpoint & Ibuprofen Can Be Administered with a Patch
Sarilumab is proving effective for treating RA. In a clinical trial, pregabalin did not meet its endpoint for treating post-traumatic peripheral neuropathic pain. And a 12-hour ibuprofen patch is in development…
Biosimilars Seek Regulatory Approval in the U.S. & Europe; Plus MTX Underused in the U.S.
In Europe, an etanercept biosimilar is getting closer to being approved to treat RA and more, and in the U.S., an application for an adalimumab biosimilar has been submitted for FDA approval. Also, an analysis of methotrexate use in the U.S. shows that therapy may actually be underused for RA…
Biologic DMARDs Prove Effective for Psoriatic Arthritis & Combination DMARDs Show Promise for RA
In clinical trials, ixekizumab and adalimumab proved safe and effective in treating adults with active psoriatic arthritis. Also, the combination therapy of certolizumab pegol plus methotrexate was more effective than placebo for treating severe RA…
New SLE Drug May Allow Patients to Reduce Steroid Use
In a recent study, the use of anifrolumab in SLE patients was shown to be safe and effective, enabling some patients to decrease their oral steroids. Also, secukinumab has been approved in Europe to treat ankylosing spondylitis and psoriatic arthritis…
Etanercept Biosimilars Promising in Clinical Studies
In multiple clinical studies, investigational biosimilars for etanercept were shown to be safe and effective for treating rheumatoid arthritis and moderate to severe plaque psoriasis…
Amgen Files for U.S. Approval of Biosimilar
(Reuters)—Amgen Inc. on Wednesday said it filed with U.S. health regulators seeking approval to sell its first biosimilar drug, which would be a less expensive alternative to AbbVie’s Humira (adalimumab), the world’s top-selling prescription medicine. Amgen said its drug, ABP 501, has demonstrated clinical equivalence and comparable safety to Humira in late stage clinical trials…
Oxycodone Capsules Put on Hold; Clinical Trials for Lupus Nephritis & SLE Therapies
Due to a lawsuit, the FDA has issued only tentative approval for an extended-release oxycodone capsule. Obinutuzumab is in clinical trials for lupus nephritis, and subcutaneous belimumab is being tested for SLE…
FDA Approves 2 Pain Drugs & New Gout Treatment on Road to Approval
The FDA has approved two drugs designed to manage pain: buprenorphine for chronic pain and meloxicam capsules for OA pain. Lesurinad is also closer to FDA approval for treating gout…
Higher Tocilizumab Dose Plus Methotrexate Best for Early RA
NEW YORK (Reuters Health)—Tocilizumab improves remission rates and slows disease progression in patients with early rheumatoid arthritis (RA), a new randomized controlled trial demonstrates. Tocilizumab was effective both on its own and when combined with methotrexate, Dr. Gerd R. Burmester of Charite Medical University of Berlin and his colleagues found. Tocilizumab, an interleukin-6 (IL-6) blocker,…
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