Drugs

Lilly Hopeful Obesity Pill Accepted in Voucher Program

Eli Lilly says its investigational weight-loss pill met most criteria for FDA’s new national priority voucher program, suggesting it is a strong candidate for a significantly accelerated approval review. The company says it will submit before the end of the year an NDA for orforglipron, and the agency will decide on the approval process, according to a Reuters report.

Earlier this month, FDA announced the first nine voucher recipients under the recently launched voucher program. Each recipient has a product with significant potential to address a major national priority, such as meeting a large unmet medical need, reducing downstream health care utilization, addressing a public health crisis, boosting domestic manufacturing, or increasing medication affordability with “Most Favored Nation” pricing, according to an agency release.

Under the program (see earlier story), drug developers may redeem the vouchers to participate in the agency pilot that shortens review times from about 10-12 months to 1-2 months following submission of a final drug application. An earlier FDA notice said the agency will convene experts for a team-based review rather than using the standard review system of a drug application being sent to numerous offices. Recently, FDA commissioner Marty Makary said the agency is looking to add additional products to the voucher program, and an announcement could be imminent.

In August, Lilly announced Phase 3 data showing the drug demonstrated significant weight loss. The ATTAIN-1 study enrolled 3,127 adults with obesity or who were overweight and at least one weight-related medical condition (except diabetes), according to the company. Over 72 weeks, all three orforglipron tested doses met the primary and all key secondary endpoints, delivering meaningful weight loss compared to placebo, it said.

Participants receiving the highest dose of orforglipron (36 mg) lost an average of 12.4% of their body weight (27.3 lbs), compared to 0.9% (2.2 lbs) in the placebo group, Lilly said. The highest also yielded improvements in cardiovascular risk markers, including reductions in triglycerides, non-HDL cholesterol, systolic blood pressure, and high-sensitivity C-reactive protein, which dropped by nearly 48%.

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

Read more

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