FDA Review of Baricitinib Delayed The U.S. Food and Drug Administration (FDA) has extended the review period for baricitinib, an investigational medication for treating moderate to severe rheumatoid arthritis (RA).1 Baricitinib is a once-daily oral Janus kinase (JAK) inhibitor currently in clinical studies for inflammatory and autoimmune diseases. The New Drug Application (NDA) for baricitinib…
EULAR has updated its recommendations for the management of early arthritis, outlining aspects of diagnosis and drug treatments…
GCA Relapse Possible When Discontinuing Tocilizumab In a Phase 2 randomized, controlled trial, tocilizumab, an anti-IL-6 biologic agent, was shown to induce and maintain remission for up to 52 weeks in patients with giant cell arteritis (GCA).1 During this trial, patients with GCA were randomized in a 2:1 ratio to receive 8 mg/kg bodyweight tocilizumab…
The FDA has released guidance for the development of biosimilars, and Medicare will cover Inflectra (infliximab-dyyb) in 2017…
NEW YORK (Reuters Health)—Secukinumab appears to improve clinical and radiographic outcomes of ankylosing spondylitis (AS) through two years of therapy, according to new results from the MEASURE 1 study. Secukinumab is a fully human monoclonal antibody against interleukin-17A, which is implicated in various pathophysiological features of spondyloarthritis. In a report online Dec. 13 in the…
NEW YORK (Reuters)—The U.S. Supreme Court on Friday agreed to hear a dispute over whether companies that make copycat versions of biologic drugs must wait six months after winning federal approval to begin selling them. The justices will take up an appeal by Novartis AG of a 2015 federal appeals court decision that prevented the…
On Jan. 6, Pfizer Inc. announced that the Centers for Medicare and Medicaid Services (CMS) has included payment information for INFLECTRA (infliximab-dyyb), a biosimilar to REMICADE (infliximab), in its January Average Selling Price (ASP) pricing file. This pricing took effect as of January 1, 2017. Additional claims processing information is listed in the MLN Matters…
A study showed that guselkumab may decrease symptoms of psoriatic arthritis and improve quality of life in adult patients…
NEW YORK—Rituximab may be an effective treatment for recalcitrant dermatitis herpetiformis (DH), according to a recent case study. “DH is an autoimmune blistering disease which is commonly associated with celiac disease and can present with debilitating pruritic blisters on extensor surfaces,” explained Dr. Ron Feldman of Emory University School of Medicine. “The most common treatments…
The makers of FX006, a steroid injection for treating pain in patients with knee osteoarthritis, have submitted a new drug application to the FDA…