ASTRAZENECA’S MedImmune biologics unit has been asked by US regulators for more information on its infant lung drug motavizumab after drug regulatory advisers recommended against approving it in June.
The request, known as a complete response letter (CRL), from the US Food and Drug Administration (FDA), asked for evidence from an additional clinical trial to support a risk/benefit profile in a patient population for which a prophylaxis indication is being requested, AstraZeneca said.
US regulators said on 25 June they were deferring a decision on the experimental lung drug for two months after outside advisers recommended against its approval in a panel review on 2 June.
“The company continues to believe in the clinical benefit of motavizumab, and it will conduct a complete review of the CRL, continue ongoing constructive dialogue with the FDA as well as make a decision regarding next steps in due course,” AstraZeneca said in a statement.
The Anglo-Swedish drugmaker’s MedImmune unit developed motavizumab to prevent serious respiratory syncytial virus (RSV) in high-risk infants. RSV is a condition affecting around 125,000 infants in the United States each year.
Given the small number of children affected by RSV, the experimental drug has not been viewed as a major product for AstraZeneca. Analysts have expressed doubt about the commercial potential of the drug.
FDA advisers said in June they were concerned data showed the new drug to be only as effective in reducing RSV hospitalisations as AstraZeneca’s current therapy Synagis, but with a greater chance of serious skin reactions.
The FDA usually follows the recommendations of its advisory committees.
AstraZeneca’s Synagis had worldwide sales of $1.1bn (£717m) in 2009.
City A.M. Reporter