The European Commission approved tofacitinib citrate to treat two pediatric conditions, as well as a prolonged-release version of the medication designed to treat adults with active PsA.
U.S. & E.U. Differ on Filgotinib for RA
This summer, the FDA rejected a new drug application for filgotinib to treat RA in the U.S., but a European Medicines Agency committee issued a positive opinion, moving filgotinib closer to authorized use in the E.U.
Abx464 Enters Phase 2 Clinical Trials for RA in Europe
In Europe, researchers are evaluating the safety, tolerability and efficacy of ABX464 in rheumatoid arthritis patients…
Piclidenoson in Trials for Psoriasis & RA; Plus Duzallo Approved in Europe
New clinical trials are underway to determine the safety and efficacy of piclidenoson for patients with plaque psoriasis and rheumatoid arthritis…
Delayed Care: Research Paints Complex Picture of Treatment Delays
AMSTERDAM—A variety of factors lead to delays in patients seeking medical care for rheumatoid arthritis—from the nature of symptoms to coping tendencies—requiring more awareness from physicians when managing patients, researchers said at EULAR: the Annual European Congress of Rheumatology. Longer delays in treatment bring about more emotional distress to patients, missed chances to ease symptoms…
EU Approves Marketing for Ixekizumab in Adults with PsA
In its second indication in the EU, ixekizumab has been approved by the European Commission to treat adults with active psoriatic arthritis…
Report on EU’s Experience with Biosimilar Drugs Released: Will U.S. Experience Be Similar?
As questions about biosimilar medications swirl among U.S. rheumatologists, a recently released report sheds some light on the European experience with biosimilars—and may offer some important insights for the U.S. market. The report, Biosimilars in the EU: Information Guide for Healthcare Professionals, was released in late April by the European Medicines Agency (EMA) and the…
European Group Offers Guidance on Managing Juvenile Dermatomyositis
NEW YORK (Reuters Health)—A European working group has formulated consensus-based recommendations for the diagnosis and treatment of juvenile dermatomyositis (JDM) with the goal of producing a “standard of care” for patients with JDM throughout Europe. The group is part of a European initiative called SHARE [Single Hub and Access point for pediatric Rheumatology in Europe]…
Europe Launches New Fast Approval Scheme for Promising Drugs
LONDON (Reuters)—European regulators launched a new scheme on Monday to speed the approval of promising new drugs that address unmet medical needs by offering enhanced support to medicine developers as they work on clinical trials. The European Medicines Agency‘s (EMA) initiative called PRIME, which stands for PRIority MEdicines, is the latest example of regulators on…
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…