Regulators in the USA have reset a final decision date on AstraZeneca's infant lung drug motavizumab which is being considered to help prevent serious respiratory syncytial virus disease.

The US Food and Drug Administration has put back the date to decide on the drug to August 27. Originally the agency was expected to deliver its final verdict on motavizumab, which is being evaluated for its potential to prevent serious lower respiratory tract disease caused by RSV in paediatric patients at high risk. from June 24; the condition affects some 125,000 infants in the USA each year.

Earlier this month, the FDA’s Antiviral Drugs Advisory Committee voted 14 to 3 to recommend that motavizumab should not be approved, claiming that the data provided merely shows that motavizumab is only as effective in reducing RSV hospitalisations as AstraZeneca’s older treatment Synagis (palivizumab). They have suggested that more clinical trials may be needed to be conducted in children, while staff documents released before the meeting stated that “we clearly have a safety signal suggesting motavizumab has more significant hypersensitivity reactions” than Synagis.

However the fact that the FDA needs more time to complete the review can be perceived as good news for AstraZeneca, and the agency does not always follows the recommendations of its advisory committees.