Drugs

JAK Inhibitors Implement FDA Class Warning

An FDA-ordered drug class warning (see earlier story) has begun appearing in labels of Janus kinase (JAK) inhibitors — Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib). In September, the agency ordered the warning after reviewing a recent clinical trial that showed an increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death with Pfizer’s arthritis and ulcerative colitis medicines Xeljanz and Xeljanz XR (tofacitinib). The safety trial compared Xeljanz with tumor necrosis factor (TNF) blockers in patients with rheumatoid arthritis. The latest warning is part of FDA’s ongoing safety review of JAK inhibitors which caused review extensions for Eli Lilly/Incyte and Pfizer submissions (see earlier story).

The class concerns arose from an FDA-required safety study when Xeljanz was approved in 2012 for rheumatoid arthritis. In 2/2019 and 7/2019, FDA warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice daily dosage, and as a result, it approved a Boxed Warning.

FDA earlier noted that “Olumiant and Rinvoq have not been studied in trials similar to the large safety clinical trial with Xeljanz, so the risks have not been adequately evaluated. However, since they share mechanisms of action with Xeljanz, FDA considers that these medicines may have similar risks as seen in the Xeljanz safety trial.”

AbbVie is the first so far to publicly announce the class-wide update, saying Rinvoq’s labeling “will now include additional information about the risks of malignancy and thrombosis, and the addition of mortality and MACE (defined as cardiovascular death, myocardial infarction and stroke) risks within the Boxed Warnings and Warnings and Precautions sections. The indication has also been updated to the following: Rinvoq is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

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FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome