Novel Antibody for Chronic Hives Brings Relief in Mid-Stage Trial
WASHINGTON — Barzolvolimab, a first-in-class anti-KIT monoclonal antibody, reduced the severity of hives in adults with chronic spontaneous urticaria (CSU) who remained symptomatic on antihistamines, a randomized phase II trial showed. Compared with placebo, several doses of the investigational drug produced greater improvement in the 7-day Urticaria Activity Score (UAS7) from baseline to week 12: […]
Novel Oral Antibiotic Effective Against Uncomplicated UTIs
Gepotidacin — a first-in-class oral antibiotic — appeared effective and safe for the treatment of uncomplicated urinary tract infections (UTIs) in a pair of large, phase III non-inferiority studies. In the two trials — EAGLE-2 and EAGLE-3 — the therapy was shown to be noninferior to nitrofurantoin, an antibiotic commonly used as a first-line therapy […]
FDA OKs Hormone-Free Pill for Hot Flashes
The FDA approved the first-in-class drug fezolinetant (Veozah) for the treatment of moderate to severe hot flashes caused by menopause, the agency announced Friday. The oral neurokinin 3 (NK3) receptor antagonist is a non-hormonal treatment that works to block the activities of the NK3 receptor, which plays a role in the brain’s regulation of body […]
Year in Review: Multiple Myeloma
Developments in multiple myeloma over the past year were marked by the approvals of a first-in-class drug for relapsed or refractory disease and a second chimeric antigen receptor (CAR) T-cell therapy, as well as some encouraging news and disappointments on the research front. New Approvals Last month, the FDA granted accelerated approval to teclistamab (Tecvayli) […]
Oral Microbiome Therapy Tied to Low Recurrence of C. Diff
A potential first-in-class investigational microbiome therapeutic, SER-109, was safe and observed to sustain low Clostridioides difficile (C. diff) recurrence rates for adults, according to the phase III, single-arm ECOSPOR IV study. Recurrence of C. diff infections occurred in 8.7% of patients at week 8 after receiving a short course of capsules containing purified Firmicutes bacteria […]
First TYK2 Inhibitor for Psoriasis Wins FDA Approval
The FDA approved the first-in-class oral tyrosine kinase 2 (TYK2) inhibitor deucravacitinib (Sotyktu) for moderate-to-severe plaque psoriasis, Bristol Myers Squibb announced. The indication limits use to adults who are candidates for systemic therapy or phototherapy. Deucravacitinib is not recommended for use with other immunosuppressant drugs. “Sotyktu has the potential to become the new standard-of-care oral […]
First GLP-1/GIP Receptor Agonist OK’d for Type 2 Diabetes
The FDA approved first-in-class tirzepatide (Mounjaro) for patients with type 2 diabetes, the agency announced on Friday. Tirzepatide, a glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide (GLP-1/GIP) agonist, is available at three dose levels (5 mg, 10 mg, and 15 mg), should be administered via injection once weekly, and is indicated as an adjunct to diet […]