(Reuters)—The U.S. Food and Drug Administration announced on Tuesday new required class-wide safety labeling changes for immediate-release opioid pain medications. Among the changes, the FDA now requires these pain medications to carry a new boxed warning about the serious risks of misuse, abuse, addiction, overdose and death. The FDA also requires several additional safety labeling…
Rheumatology Drug Updates: Opioid CR845 for OA Pain; RA Treatments in Development
CR845—an oral, peripherally selective kappa opioid agonist—is currently in Phase 2 trials for the treatment of pruritus, and acute and chronic pain.1 Eighty patients with hip osteoarthritis (OA) or knee OA were randomized to receive treatment with 0.25 mg, 0.5 mg, 1.0 mg or 5.0 mg CR845 twice daily for two weeks. Safety assessment, pharmacokinetics…
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),…
U.S. Senate Moves Closer to Confirming Califf to Lead FDA
WASHINGTON (Reuters)—The U.S. Senate on Monday moved closer to confirming Dr. Robert Califf to lead the U.S. Food and Drug Administration, overriding opposition from several senators who had sought to block a vote on the issue. In a procedural move designed to prevent the opponents from blocking the confirmation indefinitely, the Senate voted 80 to…
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…
Rheumatology Drug Updates: Biosimilars Seek Regulatory Approval in the U.S., Europe; Methotrexate Underused
Biosimilars Receive Positive News On Nov. 19, 2015, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization for SB4, an etanercept biosimilar product that will be called Benepali.1 If approved, Benepali can be used to treat rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis and plaque psoriasis….
FDA Advisory Panel Strongly Backs Biosimilar Form of Remicade
(Reuters)—A medical advisory panel to the U.S. Food and Drug Administration on Tuesday recommended approval of a cheaper biosimilar form of Johnson & Johnson’s arthritis drug Remicade (infliximab) that could eventually batter sales of the branded product. The panel, by a vote of 21-3, supported use of the biosimilar from Celltrion Inc. and Pfizer Inc.,…
Etanercept Biosimilar Approved in EU, Plus FDA Reviews Brodalumab for Plaque Psoriasis
An etanercept biosimilar referencing Enbrel and designed to treat multiple autoimmune diseases has been approved for the European market. Also, an application for subcutaneous brodalumab to treat plaque psoriasis has been submitted to the FDA…
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