NEW YORK (Reuters Health)—The selective Janus kinase 1 and 2 inhibitor baricitinib appears also to help patients whose rheumatoid arthritis (RA) has not responded adequately to biologic disease-modifying antirheumatic drugs, according to results from the RA-BEACON randomized trial. The previously published overall results from RA-BEACON showed that baricitinib-treated patients had significantly better functional and clinical…
Rheumatology Drug Updates: Biosiomilar to Adalimumab Receives FDA Approval; plus Updates on Baricitinib, Tofacitinib, Bimekizumab
FDA Approves Adalimumab-adbm On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate…
FDA Update: Biosiomilar to Adalimumab Receives FDA Approval
The FDA has approved adalimumab-adbm, a biosimilar, to treat multiple chronic inflammatory diseases…
New Insights & Approvals for Baricitinib
New research shows that baricitinib is a safe and effective RA treatment. The medication has also been approved for use in Japan and is recommended for use in the U.K…
FDA Responds to New Drug Application for Baricitinib
Oxycodone Tablets Submitted to FDA Filings for oxycodone tablets (Oxaydo) in both 10 and 15 mg doses have been accepted by the U.S. Food and Drug Administration (FDA).1 The submission is based on a pharmacokinetic study demonstrating bioequivalence to the reference drug, oxycodone hydrochloride (Roxicodone) tablets at a 15 mg dose. The product is an…
Baricitinib Approval Stalls; Plus No REMS for Erythropoiesis-Stimulating Agents
The FDA has declined to approve baricitinib to treat rheumatoid arthritis, citing the need for more data on dosing and safety…
Brodalumab Approved for Plaque Psoriasis, Plus Baricitinib Effiicacy Studied for RA
Brodalumab Approved for Plaque Psoriasis The U.S. Food and Drug Administration has approved brodalumab, a monoclonal antibody that targets interleukin 17 (IL‑17).1,2 Brodalumab (Siliq) was approved for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and have failed to respond to, or have lost response to, other…
U.S. FDA Declines to Approve Eli Lilly & Incyte Arthritis Drug
WASHINGTON (Reuters) – The U.S. Food and Drug Administration (FDA) on Friday declined to approve a new drug for rheumatoid arthritis made by Eli Lilly and Co and partner Incyte Corp, the companies said on Friday. The FDA indicated that additional clinical data was needed to determine the most appropriate doses of the drug, baricitinib…
U.S. & Europe Evaluate Abaloparatide Injection & Europe Approves Marketing Baricitinib for RA
Injectable abaloparatide is being evaluated in the U.S. and Europe to treat postmenopausal women with osteoporosis…
Baricitinib May Exhibit Better Efficacy Than Adalimumab for RA
In a recent study, baricitinib proved more effective than adalimumab in treating adults with RA through 52 weeks…