MedImmune’s respiratory treatment faces US approval delay
pharmafile | December 3, 2008 | News story | Sales and Marketing |Â Â US, reg, respÂ
One of MedImmune's key products has hit a delay in the US, after regulators demanded further data.
The FDA asked the AstraZeneca-owned company for additional information on motavizumab in its complete response letter (CRL).
The investigational monoclonal antibody was submitted to the regulator on 30 January for the prevention of serious respiratory syncytial virus (RSV) disease.
The FDA's Centre for Biologics Evaluation and Research issues CRLs at the end of a complete review cycle for a pending licence application, and they generally summarise an application's deficiencies and lay out what is needed to move things forward.
In this case, AstraZeneca says MedImmune is "confident that it can respond to the outstanding questions".
The manufacturer adds that it does not – at present – foresee a need to conduct further trials.
MedImmune said it will continue discussions with FDA reviewers and expects to re-submit in the first half of 2009.
The company is not commenting further, saying only that investors will receive an update on progress "when appropriate".
RSV infects the lungs and breathing passages. Although most people recover from after a couple of weeks, it can have a severe effect on young children and older adults.
It is also a common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under one year of age.
Monoclonal antibodies such as motavizumab are expensive and complicated to manufacture, which means their costs are often seen as outweighing their benefits.
This makes them most likely to achieve commercial success treating a high unmet need with precisely-defined target groups. There is currently no specific treatment for RSV.
MedImmune's FDA track record
This is not MedImmune's first brush with the FDA.
It received an FDA warning letter – the agency's principal means of achieving voluntary, rather than enforced, compliance from a company – last year on an unrelated issue.
During a 2006 inspection, the FDA identified some issues related to the firm's manufacture of FluMist bulk monovalent lots.
Last year it found that some of these issues had not been adequately addressed by the firm and had even continued.
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