According to new data, BMS-986165, an oral, selective tyrosine kinase 2 inhibitor, may be safe and effective for treating plaque psoriasis…
Revised Application Expected for IV Meloxicam; Plus EU Approves Tildrakizumab
After meeting with the FDA, the makers of intravenous meloxicam plan to resubmit the treatment’s new drug application…
Certolizumab Pegol Receives FDA Approval for Plaque Psoriasis
On the basis of data from multiple clinical trials, the FDA has approved certolizumab pegol for treating moderate to severe plaque psoriasis…
FDA to Review Abuse-Deterrent Oxycodone Capsule
FDA to Review Abuse-Deterrent Oxycodone Capsule In June, the FDA will discuss the New Drug Application for Remoxy ER at an Advisory Committee meeting. Remoxy ER is a 12-hour, abuse-deterrent, extended-release oxycodone in a capsule formulation.1 The capsule contains a sticky, thick, high-viscosity formulation to deter unapproved drug administration routes, including injection, smoking or snorting….
International Approvals for Guselkumab & Anakinra; Plus Adalimumab Biosimilar in Europe
In Japan the use of guselkumab to treat erythrodermic, plaque and pustular psoriasis is approved, and anakinra is now indicated for Still’s disease in the E.U…
Risankizumab Promising for Psoriasis; Plus Canada Approves Brodalumab
Two Phase 3 clinical trials show that risankizumab is effective for achieving skin clearance in patients with psoriasis…
Rheumatology Drug Updates: Hip Fracture Rates After Bisphosphonate Drug Holidays, Plus More on Golimumab, Ustekinumab
Bisphosphonate Drug Holidays Drug holidays are common for patients on bisphosphonate therapy. Often, these breaks in treatment are related to known U.S. Food and Drug Administration (FDA) warnings and drug class adverse effects. Currently, data on fracture risk related to drug holidays are limited. In recent research highlighted at the 2017 ACR/ARHP Annual Meeting ,…
Ustekinumab Approved for Use in Adolescents with Plaque Psoriasis
In October, the FDA approved ustekinumab to treat patients 12 years or older who have moderate to severe plaque psoriasis…
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…
Psoriasis May Itch as Intensely as Atopic Dermatitis
NEW YORK (Reuters Health)—Itch intensity in moderate to severe plaque psoriasis can be substantial, and may be on a par with the notoriously itchy skin condition atopic dermatitis, new research suggests. “Both conventional wisdom and some of our classic dermatologic textbooks have stated that psoriasis is not particularly itchy,” corresponding author Dr. Alexa B. Kimball…