US FDA calls for additional trial of AstraZeneca/MedImmune's RSV candidate motavizumab

31 August 2010

Anglo-Swedish drug major AstraZeneca (LSE: AZN) said yesterday that MedImmune, its USA-based biologics unit, has received a second complete response letter (CRL) on motavizumab from the US Food and Drug Administration. The company is developing the compound as a therapy for the treatment and prevention of respiratory syncytial virus (RSV) disease in babies and motavizumab is seen as a replacement for Synagis (palivizumab) before its patent expiry in 2015.

Based on the preliminary assessment of the CRL, AstraZeneca said it contains the following requirements that the company should address to advance the motavizumab registration:

' The FDA has requested evidence from an additional clinical trial that supports a satisfactory risk/benefit profile in the population(s) for which the prophylaxis indication is being requested.

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