Articles tagged with "FDA"

Infliximab Biosimilar Receives FDA Approval

Michele B. Kaufman, PharmD, BCGP | April 6, 2016

The FDA has officially approved an infliximab biosimilar for the treatment of multiple autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Prescribing information is now available…

Remicade Antibodies Cross-React to Biosimilars

Lorraine L. Janeczko | April 6, 2016

NEW YORK (Reuters Health)—Patients with antibodies to infliximab in Remicade should not be switched to biosimilars, researchers warn. “(The) antibodies will cross-react with the new biosimilar drug, potentially reducing clinical response,” Dr. Daniel Nagore, director of research and development at Progenika Biopharma in Derio, Spain, told Reuters Health by email. “The study highlights the importance…

FDA Approves Biosimilar to J&J’s Remicade for Multiple Diseases

Reuters Staff | April 6, 2016

(Reuters)—The U.S. Food and Drug Administration on Tuesday approved Inflectra, a cheaper version of Johnson & Johnson’s drug Remicade (infliximab), to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine. Inflectra, also known as infliximab-dyyb, is expected by some analysts to sell for a 25% discount to Remicade, which generated annual…

U.S. FDA Approves Lilly’s Ixekizumab for Plaque Psoriasis

Reuters Staff | March 25, 2016

(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…

FDA Says It Requires Boxed Warning on Some Opioid-Based Painkillers

Reuters Staff | March 23, 2016

(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

Michele B. Kaufman, PharmD, BCGP | March 15, 2016

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

Michele B. Kaufman, PharmD, BCGP | March 9, 2016

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

Michele B. Kaufman, PharmD, BCGP | March 2, 2016

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

Susan Bernstein | March 1, 2016

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

Toni Clarke | February 24, 2016

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…