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RSV drug rejected by FDA committee

AstraZeneca has said that a US Food and Drug Administration committee has not recommended the respiratory syncytial virus drug, motavizumab

AstraZeneca (AZ) has announced that a US Food and Drug Administration (FDA) committee has not recommended the respiratory syncytial virus (RSV) drug, motavizumab, for use in the US.

The Antiviral Drugs Advisory Committee voted 14 to 3 in favour of not giving the drug, which is used to prevent serious RSV in high-risk infants, the appropriate license for marketing. Motavizumab was developed by MedImmune, the worldwide biologics unit of AZ.

The committee had already announced concerns with the treatment, including potentially skewed respiratory admissions in local testing comparing the drug with the already approved palivizumab. The risk-benefit assessment of motavizumab was also an issue considering experiments showed it had three times as many non-fatal hypersensitivity adverse events as palivizumab.

The committee's decision is not final however, but will be considered by FDA reviewers in their licensing evaluation for motavizumab.

Despite the negative recommendation, Dr Genevieve Losonsky, vice president, Clinical Development, Infectious Disease at MedImmune, still had belief in the positive effects of the drug: "We continue to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness.

"We thank the committee for the thoroughness of its review today. We will work to address the issues raised by the committee and look forward to continuing to work with the FDA as it completes its review of our application."

Around 125,000 infants are hospitalised each year in the US as a result of RSV infections – the most common respiratory infection in infancy or childhood. Nearly all children have been infected at least once by the time they reach their second birthday.

Infants at high risk of the virus include children born prematurely, as well as those with chronic lung disease or congenital heart disease.

3rd June 2010

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