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Approvals In Brief

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck’s HPV vaccine Gardasil clears FDA June 8 for use in females ages nine to 26; CDC’s AdvisoryCommittee on Immunization Practices will review the vaccine June 29. Teva’s Parkinson’s disease therapy Azilect is approved May 16 with a Phase IV study focused on melanoma risk. Johnson & Johnson’s Remicade expands its Crohn’s disease labeling to include pediatric patients. More approvals in brief

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GSK’s Cervarix reaches FDA

GlaxoSmithKline is requesting a priority review of its human papillomavirus vaccine Cervarix, submitted March 29. The BLA is based on data from clinical trials in almost 30,000 females ages 10-55. One trial showed that Cervarix induced high antibody levels and more robust immune memory response when formulated with its proprietary AS04 adjuvant system, aluminum hydroxide plus MPL (monophosphoryl lipid A), than with aluminum hydroxide alone. GSK is looking to position Cervarix as superior to Merck's HPV vaccine Gardasil, which is formulated with aluminum hydroxide. Gardasil has been on the market since June, also under a priority review (1Pharmaceutical Approvals Monthly June 2006, p. 7)...

Merck Gardasil gets priority

FDA's action date for Merck's human papillomavirus vaccine Gardasil is June 8 following the agency's priority review designation, announced Feb. 7. Merck adds that "since submission to the FDA in December, Merck has also submitted applications for Gardasil to additional regulatory agencies including those in the European Union and Australia, Mexico, Brazil, Argentina, Taiwan and Singapore." GlaxoSmithKline recently said it plans to file a BLA for its HPV vaccine Cervarix by year-end...

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011





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