Drugs

Panel Backs Low Dose of Lilly’s Olumiant

FDA’s Arthritis Advisory Committee has recommended approval of a 2 mg dose of Eli Lilly’s Olumiant (baricitinib), a once-daily oral drug for the treating moderately-to-severely active rheumatoid arthritis for adult patients who have had an inadequate response or intolerance to methotrexate. Panel members unanimously supported the efficacy of the 4 mg dose of baricitinib, but it did not recommend approval of that dose based on the inadequacy of the safety and benefit-risk profiles.

In briefing materials released last week (see story), FDA medical reviewers said they have concerns about Olumiant’s safety, including the risk of thrombosis, that were first identified when the NDA was originally submitted 1/14/16. That application was issued a complete response letter 4/12/17 because the overall benefit-risk assessment for the proposed 2 mg and 4 mg once-daily doses was not favorable. The company resubmitted its application 12/4/17.

The reviewers said there is general agreement that the data submitted demonstrate efficacy for Olumiant in rheumatoid arthritis at doses of 2 mg and 4 mg once daily. However, they say they identified a safety profile “consistent with that of a potent immunosuppressant with major safety risks of serious and some fatal infections, including opportunistic infections and tuberculosis, malignancy, laboratory abnormalities of increase in platelet counts, decrease in neutrophil counts, and increases in lipid parameters, and serum creatine phosphokinase.” The briefing says that many of the adverse reactions appear to be dose-dependent. Also, it says, arterial and venous thromboses were observed in association with Olumiant treatment.

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