FDAnews Drug Daily Bulletin

FDA REQUEST SLOWS ID BIOMEDICAL'S DEVELOPMENT OF STREPTAVAX

Nov. 3, 2005
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The FDA has requested a "significant" amount of additional data on ID Biomedical's experimental streptococcal vaccine StreptAvax, putting a kink in the firm's development timeline for the vaccine.

ID Biomedical was originally hoping to begin testing StreptAvax, a subunit protein-based vaccine against group A streptococcal diseases, in children in the U.S. in 2005, but the firm said recently that the FDA's request could delay pediatric testing by up to two years.

The FDA informed the company during a recent pre-investigational new drug meeting that it wants to review additional information and follow-up from a recently completed adult study prior to further considering initiation of StreptAvax studies in children.

"Based on a preliminary assessment of the nature and the amount of information requested by the FDA, the company does not currently expect to begin testing the vaccine in children in the U.S. prior to 2007," the firm said. "The company expects additional dialogue with the FDA regarding the requirements for continuing development of the vaccine candidate."

In a more positive development for ID Biomedical, Health Canada cleared the firm to begin the first pediatric study for FluINsure, a non-living, intranasally delivered influenza vaccine. The Phase II study will be conducted at three centers in Canada in 160 children 3 to 12 years old.

GlaxoSmithKline announced last month that it is purchasing ID Biomedical for approximately $1.7 billion. The deal is expected to close in late 2005 or early 2006.