Recently, an FDA committee announced support for the approval of CT-P13, an infliximab biosimilar. The FDA has also fast tracked the development of a fibromyalgia treatment designed for multiple symptoms…
Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused
Biosimilars Receive Positive News 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 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
Tofacitinib Decreases Inflammation in Early RA
A recent study used MRI to show that tofacitinib reduces inflammation and inhibition of the progression of structural damage in adults with early RA…
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…
Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
Tocilizumab Plus Methotrexate Faster Fix in Some with RA
NEW YORK (Reuters Health)—In rheumatoid arthritis (RA) patients with an inadequate response to methotrexate, adding tocilizumab to the regimen is more effective than simply switching to tocilizumab, according to Japanese researchers. Dr. Tsutomu Takeuchi told Reuters Health by email that the approach “more rapidly suppressed inflammation than tocilizumab switched from methotrexate, leading to superior clinical…
3 Clinical Trials Examine Sirukumab for RA; Plus TNF-α Combination & Monotherapies Are Compared for Treating PsA
Three clinical trials are evaluating subcutaneous sirukumab for safety and efficacy in treating rheumatoid arthritis. And a study found no significant difference in persistence and remission for TNF-α monotherapy when compared with TNF-α plus conventional DMARD combination therapy for treating psoriatic arthritis…
Secukinumab Receives 2 New Approvals: PsA & AS
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…
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