AstraZeneca: FDA Resets Review Date For Motavizumab To Aug 27

AstraZeneca: FDA Resets Review Date For Motavizumab To Aug 27Astra Zeneca PLC (AZN. LN) a global bio pharmaceutical company which has the primary focus on the discovery, development and commercialization of prescription medicines, said that its one of the units MedImmune had received notice that the US food and drug Administration has reset the date of its review of motavizunab to 27th August.

Motavizumab is said to be an investigational monoclonal antibody which helps to prevent serious respiratory viral disease. MedImmune filed the original Biologic License Applications on 30th Jan 2008 and received a complete Response letter in November 2008.

In turn MedImmune filed the response to the complete response letter in December 2009 and the medicine Motavizumab was reviewed by US Food and Drug Administrations Antiviral Drugs Advisory committee on 2nd June External advisers to the FDA panel expressed their concerns that the medicine had been linked in some studies to allergic reactions plus there were doubts that the drug had any additional benefits over Synergism which is there in the market from MedImmune.

The patent of Synagis is due to expire in 2015 and the drug had generated $1.08 billion in sales last year.

Shares of Astra Zencen closed at 2997pence on Thursday it generated a value of GBP4 32billion.