November 10-15

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Home // FDA provides updates on new drug approvals, indications, and safety issues

FDA provides updates on new drug approvals, indications, and safety issues

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2 minutes

Rachel Glaser, MD
Rachel Glaser, MD

The FDA approved the first treatment for pediatric patients with lupus, among other products and drugs for new indications and populations, and made several important safety updates in 2019. Those updates were reviewed during FDA Update: Safety Issues in the Treatment of Rheumatic Disease on Monday.


“The last year has been an exciting year for the division, community, and patients,” said Rachel Glaser, MD, Clinical Team Leader of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA, who reviewed a slew of new drugs and indications during the session. 


Upadacitinib, the only new drug Dr. Glasser addressed, was approved for the treatment of moderate-to-severe rheumatoid arthritis in methotrexate inadequate responders.


In September, nintedanib (Ofev) was approved for slowing the rate of decline in pulmonary function in patients with scleroderma-associated interstitial lung disease, with the same dosing regimen as idiopathic pulmonary fibrosis — what the drug was originally approved for in 2014. Other new indications addressed included: Ixekizumab approval for active ankylosing spondylitis, apremilast approval for oral ulcers associated with Behcet’s disease, and certolizumab pegol approval for non-radiographic axial spondyloarthropathy. 


Nadia Habal, MD
Nadia Habal, MD

Belimumab, previously approved for adults with lupus, received an expanded indication to treat children 5-17 years with lupus, and rituximab was expanded for GPA/MPA pediatric patients 2 years of age or older. The previously approved indications for rituximab included non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, RA, and pemphigus vulgaris. Other approvals Dr. Glaser addressed included colchicine oral solution for gout flare prophylaxis.


Nadia Habal, MD, Medical Officer of the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA, reviewed important safety issues of interest in rheumatic diseases. Febuxostat, originally approved for treatment of hyperuricemia in patients with gout, received a boxed warning and indication revision for cardiovascular death following the CARES study, a multi-national, randomized double-blind, active controlled cardiovascular outcome trial. After an advisory committee meeting in January 2019, the FDA decided not to take it off the market since there are few treatment options for gout.


Other safety updates included a hepatotoxicity labeling update for tocilizumab and a depression and suicide labeling update for belimumab. Drug recalls for 2019 included ranitidine and angiotensin II receptor blockers.


Nikolay Nikolov, MD
Nikolay Nikolov, MD

Nikolay P. Nikolov, MD, Associate Director for Rheumatology in the Division of Pulmonary, Allergy, and Rheumatology Products at the FDA, addressed pediatric drug development, specifically for juvenile idiopathic arthritis, which is difficult due to the rare disease population, feasibility of conducting clinical trials, and since it’s a heterogeneous disease. He also addressed pediatric extrapolation, noting it has matured over the last 20 years, and it can be used to maximize the efficiency of pediatric product development while maintaining important regulatory standards for approval.


“Understanding the basic pathophysiology and natural history of disease are critically important and can build on the well-characterized exposure-response data in adults,” Dr. Nikolov said.