Drugs

Lilly Scraps Lupus Development Program

Eli Lilly says it is discontinuing its Phase 3 development program for JAK inhibitor Olumiant (baricitinib) in adults with active systemic lupus erythematosus based on top-line efficacy results from two pivotal Phase 3 trials (SLE-BRAVE-I and II). “In SLE-BRAVE-I, the baricitinib 4-mg oral dose met the primary endpoint, demonstrating a statistically significant reduction in disease activity as measured by the proportion of adults with active lupus who achieved an SRI-4 response (a composite measurement of overall disease activity) at Week 52 compared to placebo,” the company says. However, the SLE-BRAVE-II study did not meet the primary endpoint of SRI-4 response, and key secondary endpoints were not met in either study. Olumiant is currently approved for treating adults with moderately to severely active rheumatoid arthritis after treatment with one or more tumor necrosis factor blockers.

Meanwhile, Lilly says it is in ongoing discussion FDA about the status of a supplemental NDA for Olumiant for the treatment of adults with moderate-to-severe atopic dermatitis. “At this point, the company does not have alignment with the FDA on the indicated population,” it says. “Given the agency's position, there is a possibility that this could lead to a Complete Response Letter (CRL). The efficacy and safety profile of Olumiant was evaluated in eight atopic dermatitis clinical trials (six double-blind, randomized, placebo-controlled studies and two long-term extension studies) inclusive of patients whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The safety profile in these trials was consistent with previously published Olumiant data.”

JAK inhibitors have recently faced increased regulatory scrutiny based on concerns that arose from an FDA-required safety study when Pfizer’s 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. AbbVie’s similar eczema drug, Rinvoq, also faced similar regulatory hurdles before being finally approved by FDA earlier this month, as well as Pfizer’s Cibinqo.

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