The Food and Drug Administration has requested that biotech firm MedImmune conduct further study of its respiratory virus treatment motavizumab.MedImmune recieved a complete response letter from the FDA asking for an additional clinical trial of motavizumab that supports a satisfactory risk/benefit profile.MedImmune,the biologics unit of British drugmaker AstraZeneca,said it will thoroughly review the letter and make a decision in due course about motavizumab,which it says it continues to believe in.It was the second complete response letter it had recieved from the FDA in the course of seeking approval for the treatment.
Motavizumab is being investigated to treat respiratory syncytial virus,which poses a threat to certain infants and adults.RSV typically causes a mild cold-like illness that clears up within a few weeks,but can be more severe,causing pneumonia or bronchitis in young babies,premature babies or adults,especially those with chronic heart or lung problems-possibly leading to death and requiring hospitalization.
Motavizumab is a monoclonal antibody,which is an antibody produced by a cloned cell that binds to a targeted cell,potentially stimulating the patient's immune system to attack the target cell.
Based in Gaithersburg,Maryland,MedImmune employs about 3300 people worldwide.It also has facilities in Frederick,Maryland and Cambridge,U.K.
AstraZeneca(AZN)
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