Drugs

FDA Expands Rinvoq Label for Crohn’s, Ulcerative Colitis

FDA has approved an updated indication for AbbVie’s Rinvoq (upadacitinib), expanding its use in treating adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). The label update allows physicians to prescribe Rinvoq prior to tumor necrosis factor (TNF) blocker therapy for patients who have received at least one approved systemic therapy and for whom TNF inhibitors are considered clinically inadvisable. Previously, the therapy was indicated only for adults with UC or CD who had an inadequate response or intolerance to one or more TNF blockers.

Rinvoq, a Janus kinase (JAK) inhibitor, carries several serious safety warnings. According to AbbVie, the therapy may increase the risk of:

Serious and sometimes fatal infections, including tuberculosis
Death in adults aged 50 or older with cardiovascular risk factors
Certain cancers, including lymphoma and lung cancer, particularly in current or former smokers
Major cardiovascular events such as heart attack or stroke
Blood clots in the veins or lungs
Serious allergic reactions and gastrointestinal tears

Rinvoq is also undergoing Phase 3 trials for conditions such as alopecia areata, hidradenitis suppurativa, systemic lupus erythematosus, and vitiligo, according to the company.

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’

Overton Confirmation Remains Uncertain After Senate Hearing

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

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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