Juvenile Arthritis News

Amgen announced in a press release that the FDA has accepted to review its supplemental biologics license application for expanding the use of Enbrel to treat pediatric patients with chronic severe plaque psoriasis.

HOLLYWOOD, Fla. — R. John Looney, MD, professor of medicine at the Stephen I. Rosenfeld Professor of Allergy and Clinical Immunology at the University of Rochester in Rochester, N.Y. spoke with Healio.com/Rheumatology about the role of tolerance in autoimmune diseases.

A sustained response was observed in pediatric patients with juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis or extended oligoarthritis treated with etanercept over 96 weeks with no serious adverse events, according to recently published research.

At the Generic Pharmaceutical Association Annual Meeting in Orlando, Florida, the Biosimilars Council Chair and Pfenex Chief Executive Officer Bertrand Liang, MD, PhD, hosted a panel discussion with members of the pharmaceutical, biosimilar and heath care industries about regulatory issues, according to a statement released to Healio Rheumatology.

Researchers identified five predictive factors for the discontinuance of biologic medication by patients with chronic inflammatory rheumatic diseases, according to recently published research of French patients.

Sandoz, a Novartis company, announced it has acquired the rights to Pfizer’s biosimilar to infliximab to develop and commercialize across the 28 countries comprising the European Economic Area, according to a company press release.

Members of the FDA Arthritis Advisory Committee voted positively today for the recommendation to approve the biologics license application of Celltrion’s CT-P13 biosimilar to infliximab. If approved, CT-P13 would be the first biosimilar monoclonal antibody to be approved for use in the United States.

The FDA has recently released a briefing document ahead of its scheduled hearing on Feb. 9 to consider the approval of Celltrion’s CT-P13 biosimilar to infliximab.

The presence of sacroiliitis as evidenced on MRI was common in a study of children with juvenile spondyloarthritis, and HLA-B27-positivity and elevated C-reactive protein were most likely to predict the presence of sacroiliitis, according to recently published research.

Amgen recently announced in a press release that the FDA has accepted its biologics license application for ABP 501, Amgen’s biosimilar to adalimumab, for review.