Breastfeeding While Taking MS Monoclonal Antibody Drugs Appears Safe
Exposure to multiple sclerosis (MS) monoclonal antibody treatment during breastfeeding appeared to have no negative effect on the early development or health of infants, registry data in Germany showed. Over the first 3 years of follow-up, no links emerged between exposure to monoclonal antibody drugs and annual hospitalization (rate ratio [RR] 1.23, P=0.473), annual systemic […]
Investigational Agent Shows Benefit in Myasthenia Gravis
The investigational monoclonal antibody batoclimab led to significant improvement in activities of daily living in people with generalized myasthenia gravis (gMG), a multicenter phase III trial found. The rate of sustained improvement on Myasthenia Gravis Activities of Daily Living (MG-ADL) scores for antibody-positive patients in the first treatment cycle was 58.2% in the batoclimab group […]
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: […]
Nirsevimab Reduced Hospitalizations for Infants With RSV
The monoclonal antibody nirsevimab (Beyfortus) reduced hospitalizations among infants with respiratory syncytial virus (RSV)-associated lower respiratory tract infection, the randomized, pragmatic HARMONIE trial showed. In over 8,000 infants included in the study, 0.3% who received nirsevimab were hospitalized for RSV-associated lower respiratory tract infection compared with 1.5% of those who received standard care, which corresponded […]
Few Early Alzheimer’s Patients Qualify for Lecanemab
Few people with early Alzheimer’s disease met eligibility criteria for the new anti-amyloid monoclonal antibody treatments lecanemab (Leqembi) and aducanumab (Aduhelm), cross-sectional data from the Mayo Clinic Study of Aging showed. Of 237 people with mild cognitive impairment or mild dementia and increased brain amyloid on PET, clinical trial inclusion and exclusion criteria narrowed the […]
Mirikizumab Benefit in UC Extends Into Maintenance Phase
The investigational monoclonal antibody mirikizumab was more effective in inducing and maintaining clinical remission in patients with moderate to severe ulcerative colitis (UC) compared with placebo, according to two phase III randomized trials. Among over 1,200 patients in the LUCENT-1 induction trial, 24.2% of those who received mirikizumab experienced clinical remission at week 12 compared […]
FDA Panel Endorses mAb to Prevent RSV in Infants
An FDA advisory committee on Thursday gave strong backing to a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age. In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the […]
Antibody for Infant RSV Prevention to Face FDA Panel
An FDA advisory committee on Thursday will consider whether to recommend a shot of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease in both infants and in at-risk children up to age 2 years. The Antimicrobial Drugs Advisory Committee will examine a biologics license application approval for nirsevimab, a […]
Monoclonal Antibodies Linked to Reduced RSV Burden in Young Kids
Prophylactic use of three monoclonal antibodies was associated with substantial reductions in respiratory syncytial virus (RSV)-related infections and hospitalizations in children under 5, a systematic review and meta-analysis showed. Across 14 randomized controlled trials involving over 18,000 high-risk children, moderate- to high-certainty evidence showed that nirsevimab, palivizumab, and motavizumab were associated with significant reductions in […]
Anti-CD20 Agent Gains Approval for Multiple Sclerosis
Ublituximab (Briumvi), a monoclonal antibody targeting CD20, was approved for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, TG Therapeutics announced. The FDA’s decision was based on two identical phase III trials of people with relapsing MS, ULTIMATE I and ULTIMATE II. At 96 weeks, ublituximab […]