* FDA wants additional evidence for prophylaxis indication
* Astra says continues to believe in motavizumab
* Firm says will make decision on next steps in due course
(Adds details, quote from company, background)
LONDON, Aug 30 (Reuters) - AstraZeneca’s MedImmune biologics unit has been asked by U.S regulators for more information on its infant lung drug motavizumab after drug regulatory advisors recommended against approving it in June.
The request, known as a complete response letter (CRL), from the U.S. 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 on Monday.
U.S. regulators said on June 25 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 June 2. [ID:nLDE65O05T]
“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,” Astra 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 serious 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, which has already faced delays.
FDA advisers said on June 2 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. [ID:nN02194000]
The FDA usually, although not always, follows the recommendations of its advisory committees.
AstraZeneca’s Synagis had worldwide sales of $1.1 billion in 2009. (Reporting by Kate Kelland; Editing by Dan Lalor, Mike Nesbit)
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