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Merck Zostavax data

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

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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Merck Zostavax BLA

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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