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Merck Zostavax BLA

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck submits BLA April 25 for its herpes zoster vaccine Zostavax. The firm is seeking claims for prevention of herpes zoster (shingles); prevention of postherpetic neuralgia, the most common complication of shingles; and reduction of acute and chronic shingles-associated pain in adults. The firm estimates that up to 800,000 people in the U.S. suffer from shingles each year. Merck plans to submit another vaccine this year: the human papilloma virus vaccine Gardasil is slated for submission in the second half of the year (1Pharmaceutical Approvals Monthly April 2005, In Brief)...

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Merck's shingles vaccine Zostavax (herpes zoster vaccine live (Oka/Merck)) reduced both total pain burden and postherpetic neuralgia by more than 60%, according to a 38,500-patient study published in the June 2 New England Journal of Medicine. The Phase III Shingles Prevention Study showed that the vaccine reduced total burden of pain and discomfort by 61.1% and postherpetic neuralgia by 66.5% (p<0.001). Overall shingles incidence was also significantly reduced, by 51.3%. Merck submitted a Zostavax BLA to FDA April 25 but has not yet been notified regarding a priority review designation (1Pharmaceutical Approvals Monthly May 2005, In Brief)...

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