Motavizumab

Monoclonal antibody
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Motavizumab (proposed INN, trade name Numax) is a humanized monoclonal antibody. It is being investigated by MedImmune (today a subsidiary of AstraZeneca) for the prevention of respiratory syncytial virus infection in high-risk infants.[1] As of September 2009[update], it is undergoing Phase II and III clinical trials.[2]

In June 2010, the FDA Antiviral Drugs Advisory Committee declined to endorse MedImmune's request for licensure of Motavizumab in a 14 to 3 decision. The members of that panel cited several reasons for the decision, and many were concerned that "we're not looking at a product that has evidence of superiority in terms of efficacy" when compared to the already available monoclonal antibody Palivizumab.[3]

In December 2010, AstraZeneca in a stock market statement stated that it would be writing down $445m (£286m) after discontinuing a key development programme for Motavizumab. The company stated that it would no longer develop Motavizumab for the prevention of respiratory syncytial virus (RSV), and as a result was withdrawing its licence application to the US Food and Drug Administration. It added that it would continue to develop Motavizumab for other treatments of RSV.[4]

References

  1. ^ Kalergis AM, Soto JA, Gálvez NM, Andrade CA, Fernandez A, Bohmwald K, Bueno SM (December 2020). "Pharmacological management of human respiratory syncytial virus infection". Expert Opinion on Pharmacotherapy. 21 (18): 2293–2303. doi:10.1080/14656566.2020.1806821. PMID 32808830. S2CID 221163435.
  2. ^ ClinicalTrials.gov
  3. ^ "FDA Panel Nixes Licensing Request for Motavizumab". Medscape. 3 June 2010. Retrieved 2014-03-02.
  4. ^ "AstraZeneca halts work on Motavizumab drug". BBC News. 21 December 2010. Retrieved 2010-12-21.

External links

  • "Motavizumab". Drug Information Portal. U.S. National Library of Medicine.
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