Drugs

Lilly Begins Covid Trial of Baricitinib

Eli Lilly says it has enrolled the first patient in a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with Covid-19. Baricitinib, marketed as Olumiant, is approved in 70 countries for treating moderately to severely active rheumatoid arthritis. Lilly expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the U.S., Europe and Latin America and includes patients hospitalized with Covid-19 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry, the company says.

It is believed that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications from the infection, Lilly says. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more virus.

The primary endpoint in the study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by day 28 in patients treated with 4 mg of baricitinib daily (with background therapy) compared to placebo (with background therapy). Patients will receive baricitinib or placebo for up to 14 days or until discharged from the hospital.

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