Monoclonal antibodies on Notably News

Monoclonal antibodies

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March 2024	Monoclonal antibody US FDA granted emergency use authorization to pemivibart, a monoclonal antibody drug, for pre-exposure prophylaxis in moderately to severely immunocompromised individuals against COVID-19.
January 2024	Casirivimab/imdevimab Clinical observations published recording full remission of long COVID symptoms in 3 patients treated with Casirivimab/imdevimab, though the treatment was not originally intended for long COVID.
July 2023	Monoclonal antibody therapy The FDA granted full approval to Lecanemab (commercial name Leqembi) for the treatment of Alzheimer's Disease, marking a significant milestone in monoclonal antibody therapy for the condition.
2022	Monoclonal antibody Cochrane reviews found insufficient evidence for using neutralizing monoclonal antibodies to treat COVID-19 infections, with studies limited to existing COVID-19 variants.
January 2022	Casirivimab/imdevimab U.S. Food and Drug Administration (FDA) revised authorizations for casirivimab/imdevimab, limiting its use to only variants susceptible to the treatment due to ineffectiveness against the Omicron variant.
2021	Monoclonal antibody Cochrane reviews found insufficient evidence for using neutralizing monoclonal antibodies to treat COVID-19 infections in unvaccinated individuals.
November 2021	Casirivimab/imdevimab The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting a marketing authorization for casirivimab/imdevimab (Ronapreve) in the European Union for COVID-19 treatment and prevention.
September 2021	Casirivimab/imdevimab World Health Organization urged producers and governments to address the drug's high cost and called for technology sharing to enable the manufacture of biosimilar versions of casirivimab/imdevimab.
September 2021	Monoclonal antibody Biden administration purchased billions of dollars worth of Regeneron monoclonal antibodies at $2,100 per dose to address COVID-19 treatment shortages.
September 14 2021	Casirivimab/imdevimab United States government purchased an additional 1.4 million doses for $2.94 billion.
August 2021	Casirivimab/imdevimab Texas Governor Greg Abbott received REGEN-COV after testing positive for COVID-19.
July 2021	Casirivimab/imdevimab US FDA revised the emergency use authorization to include post-exposure prophylaxis (prevention) for COVID-19 in people twelve years and older at high risk of severe progression.
June 2021	Casirivimab/imdevimab Preliminary Recovery trial results showed reduced mortality from 30% to 24% in participants who had not produced their own antibodies.
May 2021	Casirivimab/imdevimab Roche India and Cipla announced the medicine would be available in India.
May 5 2021	Casirivimab/imdevimab India's Central Drugs Standards Control Organisation (CDSCO) granted Emergency Use Authorization to Roche and Regeneron for casirivimab/imdevimab cocktail during the second wave of the COVID-19 pandemic.
April 2021	Casirivimab/imdevimab Roche and Regeneron announced Phase III clinical trial REGN-COV 2069 results, showing 81% reduction in infection risk for non-infected participants and reduced symptom resolution time.
February 2021	Casirivimab/imdevimab European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) began a rolling review of data on the REGN-COV2 antibody combination for COVID-19 treatment and prevention.
January 2021	Casirivimab/imdevimab United States government purchased 1.25 million doses of the drug for $2.625 billion, at $2,100 per dose.
January 2021	Casirivimab/imdevimab German government purchased 200,000 doses for €400 million at €2,000 per dose.
2020	Monoclonal antibody US Food and Drug Administration granted emergency use authorizations for monoclonal antibody therapies bamlanivimab/etesevimab and casirivimab/imdevimab to reduce COVID-19 hospitalizations, emergency room visits, and deaths.
November 21 2020	Casirivimab/imdevimab U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for treating mild to moderate COVID-19 in people twelve years or older at high risk of severe progression.
October 2 2020	Casirivimab/imdevimab Regeneron Pharmaceuticals announced that US President Donald Trump received a single 8-gram dose of REGN-COV2 after testing positive for SARS-CoV-2, with the drug provided under a 'compassionate use' authorization.
September 2020	Casirivimab/imdevimab Regeneron began shifting production of existing products from its Rensselaer, New York manufacturing facility to Limerick, Ireland to free up manufacturing capacity for REGEN-COV (casirivimab/imdevimab) antibody treatment.
June 2019	Monoclonal antibody therapy Polatuzumab vedotin (Polivy) approved, targeting CD79B.
September 2018	Monoclonal antibody therapy Cemiplimab (Libtayo) approved, targeting PD-1.
September 2018	Monoclonal antibody therapy Moxetumomab pasudotox (Lumoxiti) approved, targeting CD22.
August 2018	Monoclonal antibody therapy Mogamulizumab (Poteligeo) approved, targeting CCR4.
December 2012	Monoclonal antibody therapy DIAN-TU study launched, focusing on young patients with genetic mutations that are risk factors for Alzheimer's Disease. The study investigates Solanezumab and Gautenerumab as potential preventive treatments.

This contents of the box above is based on material from the Wikipedia articles Monoclonal antibody therapy, Casirivimab/imdevimab & Monoclonal antibody, which are released under the Creative Commons Attribution-ShareAlike 4.0 International License.