(Reuters)—U.S. health regulators said on Tuesday they have approved a drug from Eli Lilly and Co. to treat adults with moderate to severe cases of plaque psoriasis. The injectable drug known chemically as ixekizumab will be sold under the brand name Taltz, the U.S. Food and Drug Administration said. Taltz works by blocking interleukein-17A, a…
From the Expert: Patient Access Is Key for Biosimilars in Development to Be Effective
Recent research by Michael Weinblatt, MD, and colleagues has demonstrated that a biosimilar derived from adalimumab is both effective and safe for treating patients with rheumatoid arthritis. But Dr. Weinblatt says, the benefits of such biosimilars hinge on cost and patient access…
Plaque Psoriasis: Secukinumab Beats Ustekinumab in a Head-to Head Clinical Trial & Ixekizumab Helps Improve Productivity
In a 52-week clinical trial, patients with plaque psoriasis who took secukinumab achieved greater sustained skin clearance then those taking ustekinumab. Also, three clinical trials showed ixekizumab improves work productivity in patients with plaque psoriasis…
Psoriasis Drug Succeeds in Mid-Stage Study
(Reuters)—Drug developer Vitae Pharmaceuticals Inc. said its experimental psoriasis drug significantly reduced the skin condition in patients from a mid-stage trial, sending its shares up 70% in after-hours trading. Patients taking a 350 mg dose of the drug, VTP-43742, showed a 24% reduction, while patients who took the 700 mg dose showed a 30% reduction…
Clinical Trials: Zilretta Promising for Knee OA Pain & Golimumab Completes Phase 3 Trial
In recent Phase 3 clinical trials, Zirletta proved effective in managing pain for patients with knee osteoarthritis, and subcutaneous golimumab helped patients with psoriatic arthritis achieve long-term functional improvement…
The ACR Addresses the FDA about the Safe Adoption of Biosimilars in the U.S.; Plus Tofacitinib Approved for RA & Romosozumab May Reduce Fracture Risk
The ACR has continued its advocacy to ensure the safe adoption of biosimilars in the U.S., most recently addressing an FDA public hearing. Also, the FDA has approved tofacitinib for RA, and a clinical trial of romosozumab for patients with osteoporosis met its primary endpoint…
Tofacitinib Released from FDA REMS Requirement; Plus Biosimilars for Etanercept & Adalimumab Show Promise
Tofacitinib has been released from the FDA’s risk evaluation and mitigation strategy requirement. The FDA is also reviewing a biologics license application for ABP-501, an adalimumab biosimilar. And CHS-0214, a proposed etanercept biosimilar, has met its primary endpoint at Week 24 in an ongoing 52-week study…
The Biosimilars Debate Heats Up: Potential cost savings weighed against patient health & safety
After years of speculation about potential cost savings and debates on safety, biosimilars are about to step onto the stage of rheumatic disease treatment. On Feb. 9, the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) met in Washington, D.C., and recommended the approval of CT-P13, a proposed biosimilar to infliximab (Remicade),…
Apremilast Proves Effective for PsA with Skin Involvement
A recent Phase 3 clinical trial found apremilast safe and effective for treating patients with active psoriatic arthritis and skin symptoms who found conventional and biologic DMARDs ineffective…
FDA Update: Infliximab Biosimilar Garners Support & Fibromyalgia Drug Receives Fast Track
Recently, an FDA committee announced support for the approval of CT-P13, an infliximab biosimilar. The FDA has also fast tracked the development of a fibromyalgia treatment designed for multiple symptoms…
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