In the E.U., secukinumab is edging closer to approval for use in pediatric patients with juvenile idiopathic arthritis (JIA), specifically those with enthesitis-related arthritis (ERA) and juvenile psoriatic arthritis (PsA). In May, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on expanding its indications.
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.
(Reuters)—Europe’s drugs regulator said on Monday it was evaluating the use of Roche’s arthritis drug, tocilizumab, in hospitalized adults with severe COVID-19, its latest review of a potential coronavirus treatment. Tocilizumab, sold by Roche as Actemra and RoActemra, has shown promise in clinical trials in treating COVID-19, and was approved by U.S. health regulators in…
In January, upadacitinib was approved for use in Europe as a 15 mg, once-daily dose to treat patients with psoriatic arthritis and ankylosing spondylitis.
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.
Upadacitinib will soon be available to treat patients with moderate to severe rheumatoid arthritis in Canada and the E.U…
In late July, the European Commission granted marketing approval for Hyrimoz, which is biosimilar to adalimumab…
In its second indication in the EU, ixekizumab has been approved by the European Commission to treat adults with active psoriatic arthritis…
Subcutaneous belimumab has been approved in the EU to help treat patients with active autoantibody-positive SLE…
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…