Disease outcomes in rheumatoid arthritis (RA) have improved dramatically since the introduction of biologic agents and improved treatment strategies. Nevertheless, the majority of patients still require prolonged, if not lifelong, therapy. Therefore, the ultimate goal would be to prevent RA. This study analyzed the effect of a one-year course of methotrexate in high-risk UA patients (studied in a previous trial) after post-randomization exclusion of patients without a high risk of developing RA…
FDA to Review Immediate-Release Oxycodone; Plus NICE Recommends Secukinumab
A new formulation of oxycodone in 10 and 15 mg doses is being reviewed by the FDA for treating pain…
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…
U.S. Top Court Debates Making Copycat Biologics Available Sooner
WASHINGTON (Reuters)—U.S. Supreme Court justices on Wednesday struggled over whether to speed up the time it takes to bring to the market copycat versions of biologic drugs, expensive medicines that can generate billions of dollars in sales for drug makers. The nine justices heard arguments in an appeal by Novartis AG of a lower court…
EMA Panel Recommends Nod for Sanofi, Regeneron’s Arthritis Drug
(Reuters)—A European Medicines Agency panel said on Friday it recommended granting marketing approval to Sanofi and Regeneron’s experimental drug to treat rheumatoid arthritis (RA). The Committee for Medicinal Products for Human Use gave a positive opinion on the drug, sarilumab (Kevzara), citing its ability to reduce the signs and symptoms of RA. Sarilumab, the active…
Valeant Prices Psoriasis Treatment at $3,500 Per Month
(Reuters)—Canadian drug maker Valeant Pharmaceuticals International Inc. said it had priced its recently approved plaque psoriasis treatment at $3,500 per month, ahead of an expected U.S. launch in the second half of 2017. Brodalumab (Siliq) is the lowest priced injectable biologic psoriasis treatment currently on the market, Valeant says. Drugmakers are facing intense criticism from…
NKTR-181 Promising for Chronic Low Back Pain
NKTR-181, a mu-opioid agonist analgesic, has proved safe and effective for treating chronic low back pain vs. placebo in a recent clinical trial…
Tocilizumab Effectively Treats Early RA for Up to Two Years
NEW YORK (Reuters Health)—Patients with early rheumatoid arthritis (RA) treated with IV tocilizumab alone or with methotrexate maintained clinical benefits during their second year of treatment, researchers say. Sophie Dimonaco of Roche Products Ltd. in Welwyn Garden City, UK and colleagues sought to determine whether the efficacy and safety of IV tocilizumab, as demonstrated in…
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…
Biosimilar Drugs Raise Questions around Treatment Efficacy, Quality, Safety
WASHINGTON, D.C.—Challenges abound for the manufacturing of biosimilar drugs—from their sheer size compared with small molecule drugs to the unknowable proprietary aspects of the originator drugs—an expert said at the 2016 ACR/ARHP Annual Meeting in a session titled Immunology Update: Biologic Agents: From Nature to Protein Engineering to Biosimilars. Above all, because biosimilars are copies…
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