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US FDA approves Eisai-Biogen’s antibody for Alzheimer’s

Pharmaceutical Technology

Eisai and Biogen have received approval for their antibody Leqembi (lecanemab-irmb) , 100mg/mL injection for intravenous use, from the US Food and Drug Administration (FDA) under the Accelerated Approval Pathway to treat Alzheimer’s disease (AD). The regulatory approval is based on the data obtained from the Phase II trial.

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Antibody treatment for geographic atrophy enters clinical trials

Drug Discovery World

Collaborators Boehringer Ingelheim and CDR-Life have commenced a Phase I evaluation of BI 771716, their antibody fragment-based treatment developed to preserve the vision of people with geographic atrophy (GA). The company’s first therapeutic candidate, CDR404, targets MAGE-A4 and is expected to enter the clinic in 2024.

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Epsilogen completes first-ever IgE antibody clinical trial

BioPharma Reporter

Epsilogen, a leader in the development of immunoglobulin E (IgE) antibodies to treat cancer, has published phase 1 data from the first ever clinical trial of an IgE antibody therapeutic in Nature Communications.

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Sanofi and AstraZeneca’s RSV antibody shows mettle in real-world results

Pharmaceutical Technology

Sanofi announced data from a real-world clinical trial that demonstrated its RSV antibody nirsevimab delivered an 83% reduction in hospitalisations in infants with respiratory syncytial virus (RSV)-related lower respiratory tract disease (LRTD). Nirsevimab is being jointly developed between Sanofi and AstraZeneca.

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AstraZeneca to deliver Covid-19 antibody therapy doses to Switzerland

Pharmaceutical Technology

AstraZeneca has signed a deal with the Federal Office of Public Health (FOPH) of Switzerland to deliver over 1,200 doses of antibody therapy, tixagevimab and cilgavimab combination (AZD7442), for Covid-19 prevention and treatment. In June 2020, these antibodies, discovered at Vanderbilt University Medical Center, were licensed to AstraZeneca.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In an optimised dose clinical trial, randomised dose-ranging allows companies to find the dose above which there is no evidence of incremental benefit, particularly if higher doses cause increased toxicities. In clinical trials, dose-ranging is testing different drug doses against each other to establish which works best.

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Monoclonal Antibody Lecanemab Finalizing Clinical Trials for Alzheimer’s Disease Treatment

XTalks

This year, the monoclonal antibody lecanemab is approaching final stages of investigation as a treatment for targeting the A? The Phase IIb clinical trial focused on the long-term clinical outcomes and safety for patients with MCI and amyloid pathology (early AD). The main pathological markers of AD are beta-amyloid (A?)