Drugs

Alumis Positive Data Reported for Psoriasis Drug

Alumis says its oral tyrosine kinase 2 inhibitor envudeucitinib delivered high levels of skin clearance in two pivotal Phase 3 trials in moderate-to-severe plaque psoriasis, which would position the drug among the most effective next-generation oral therapies for the disease. The company reports that both Phase 3 ONWARD1 and ONWARD2 trials met all primary and secondary endpoints with high statistical significance, beating placebo on standard measures of disease improvement and also outperforming the oral comparator apremilast.

Across the two studies, the company says an average of 74% of patients treated with the drug achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI 75) at Week 16, while 59% reached a static Physician’s Global Assessment score of clear or almost clear. Responses improved over time, with about 65% of patients reaching PASI 90 and more than 40% achieving complete skin clearance (PASI 100) by Week 24. Rapid efficacy was also observed, with separation from placebo on PASI 90 as early as Week 4, it adds.

Alumis says the treatment was generally well tolerated through 24 weeks, with a safety profile consistent with earlier studies. The most common treatment-emergent adverse events included headache, nasopharyngitis, upper respiratory tract infections, and acne, most of which were mild to moderate. No new safety signals were identified.

Alumis plans to submit an NDA in the second half, and to present additional data from the ONWARD program at an upcoming medical meeting. The company is also evaluating the drug in systemic lupus erythematosus, with Phase 2b data expected in the third quarter.

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