Drugs

Lilly Sees Positive Data in Taltz–Zepbound Combo

Eli Lilly is reporting that combining its psoriasis biologic Taltz (ixekizumab) with obesity drug Zepbound (tirzepatide) led to significantly greater skin clearance and weight loss than Taltz alone in adults with moderate-to-severe plaque psoriasis and obesity or who are overweight. Topline results from the 52-week Phase 3b TOGETHER-PsO study showed that at 36 weeks, 27.1% of patients receiving the combination achieved complete skin clearance— defined as Psoriasis Area and Severity Index (PASI) 100 — along with at least 10% weight loss, according to the company. By comparison, 5.8% of patients treated with Taltz monotherapy met the dual endpoint.

In a key secondary endpoint, it says 40.6% of patients receiving both drugs achieved PASI 100, compared with 29.0% of those on Taltz alone — a 40% relative increase.

Lilly says the study population represented a particularly high disease burden. The average BMI across treatment arms exceeded 39 kg/m²—substantially higher than populations typically studied in pivotal psoriasis biologic trials. Most participants had extensive skin involvement, with roughly a quarter of body surface area affected, and 97% had psoriasis in high-impact areas such as the face, scalp or genitals.

Company executives and investigators frame the results as evidence supporting a more integrated approach to treating psoriasis and obesity, conditions that share inflammatory pathways and frequently co-occur. In the U.S., Lilly notes, about 61% of people with psoriasis also have obesity or are overweight with at least one weight-related comorbidity.

Adverse events in the combination arm were generally mild to moderate and consistent with the known safety profiles of each drug, Lilly says. The most common events (greater than 5%) with concomitant therapy included nausea, diarrhea, constipation, injection-site reactions, dosing errors, vomiting and dizziness. In the Taltz-only arm, common events included injection-site reactions, dosing errors and nasopharyngitis.

Taltz is an interleukin-17A inhibitor approved for moderate-to-severe plaque psoriasis in adults and children age six and older, as well as for psoriatic arthritis and certain forms of axial spondyloarthritis. Zepbound is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved for chronic weight management.

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