Drugs

AbbVie Files Rinvoq sNDA for Ulcerative Colitis

AbbVie has submitted a supplemental BLA for Rinvoq (upadacitinib) (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for treating adults with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

The submission is based on data from two Phase 3 induction studies and one maintenance study. “In these studies, significantly more patients treated with upadacitinib achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and all secondary endpoints compared to placebo with 45 mg once daily at week eight for the induction studies, and with 15 mg and 30 mg once daily at 52 weeks for the maintenance study,” the company says. Safety results were consistent with Rinvoq’s known safety profile, it adds.

Rinvoq was originally approved in 2019 for treating adults with moderate to severe rheumatoid arthritis in whom methotrexate did not work well or could not be tolerated.

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