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)...