Drugs

Inspection Derails Lilly Eczema BLA

FDA has issued Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treating moderate-to-severe atopic dermatitis (eczema). The agency letter cited findings that arose during a multi-sponsor inspection of a third-party contract manufacturer, according to the company. The letter cited no concerns about the clinical data package, safety or label for lebrikizumab, it says, adding that it will “continue to work closely with the third-party manufacturer and the FDA to address the feedback in order to make lebrikizumab available to patients.”

Lilly describes lebrikizumab as a novel, monoclonal antibody that binds to the interleukin 13 (IL-13) protein. IL-13 plays a large role in Type 2 inflammation in atopic dermatitis (AD), it says. The submission contained data from ADvocate 1, ADvocate 2 and ADhere studies, Lilly says, which included over 1,000 adults and adolescents (ages 12 and older) with moderate-to-severe eczema who were unable to control their symptoms with topical medicines or other systemic treatments. Lilly previously said clinical data showed that the therapy in combination with standard-of-care topical corticosteroids (TCS) achieved at least 75% improvement in overall disease severity compared to a placebo plus TCS. The company said that the data from its Adhere trial also showed improvements in itch, sleep interference, and quality of life when combined with TCS, compared to placebo plus TCS. “Among patients taking lebrikizumab plus TCS, 41% achieved clear or almost clear skin (IGA) at 16 weeks compared to 22%of patients taking placebo plus TCS,” it adds.

Regarding safety, Lilly says data were consistent with prior lebrikizumab studies in AD. “Most adverse events were mild or moderate in severity and nonserious and did not lead to treatment discontinuation,” it says, adding that the most common adverse events for those on lebrikizumab were conjunctivitis (5%) and headache (5%).

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