FDA Staff Sees Allergic-Reaction Risk With Motavizumab
May 28 2010 - 9:07AM
Dow Jones News
U.S. Food and Drug Administration staff said they are concerned
about the risk for serious allergic reactions with a proposed
AstraZeneca PLC (AZN) drug designed to prevent a respiratory
infection in pre-term babies.
AstraZeneca's U.S.-based MedImmune unit is seeking FDA approval
of the product, motavizumab, to be administered to babies
considered at high risk for developing respiratory syncytial virus
or RSV, a virus that affects the lungs and can be fatal.
The company already makes a similar product that's sold as
Synagis. Motavizumab is designed to be more effective than Synagis,
which is also known by its generic name palivizumab.
The FDA's antiviral drug products advisory committee will review
motavizumab at a June 2 meeting. The FDA released its review of the
product on its website Friday.
The panel of non-medical experts is being asked to vote on
whether it thinks motavizumab should be approved.
The FDA's review, however, suggests the agency thinks
motavizumab should not be approved given that Synagis is already on
the market.
"We clearly have a safety signal suggesting motavizumab has more
significant hypersensitivity reactions than palivizumab [Synagis],"
the FDA said. The agency said the product has three times as many
allergic reactions as Synagis.
MedImmune, in a background document also posted to the FDA's
website Friday, said motavizumab is effective in decreasing serious
RSV disease in high-risk children. The company suggested that
health care professionals would be able to monitor patients for
allergic reactions and stop treatment if needed.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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