Zostavax
zoster vaccine live (Oka/Merck)
Treatment for Herpes Zoster -- ProphylaxisMerck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain
WHITEHOUSE STATION, N.J., May 2, 2005 - Merck & Co., Inc. announced today that it has submitted to the U.S. Food and Drug Administration (FDA) a Biologics License Application for Zostavax (zoster vaccine live (Oka/Merck)), an investigational vaccine for the prevention of herpes zoster, commonly known as "shingles;" prevention of postherpetic neuralgia (PHN), the persistent, long-term nerve pain that is the most common complication of shingles; and the reduction of acute and chronic shingles-associated pain in adults.
Merck submitted the application for Zostavax on April 25. Within the next 60 days, the FDA will determine whether it will accept for review Merck's application as submitted.
About Shingles and Postherpetic Neuralgia
Shingles occurs when the varicella-zoster virus that causes
chickenpox reactivates after lying dormant in the body, typically
after several decades. Shingles may first appear as tingling,
itching or pain on one side of the body or face. It then progresses
to a blistering rash accompanied by pain in almost every case that
varies in intensity and duration. Shingles also can lead to
complications, including persistent, often debilitating nerve pain
(PHN) that can follow an episode of shingles. Approximately 25 to
50 percent of shingles patients older than 50 years of age develop
chronic pain after shingles (PHN).
Shingles can affect anyone who has had chickenpox -- more than 90 percent of adults in the United States -- and occurs most frequently in people over 50 years of age. In fact, up to half of all people living to age 85 will develop shingles during their lifetime. It is estimated that up to 800,000 people in the United States suffer from shingles each year, and the incidence is expected to increase as the population ages.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical
company dedicated to putting patients first. Established in 1891,
Merck discovers, develops, manufactures and markets vaccines and
medicines in more than 20 therapeutic categories. The company
devotes extensive efforts to increase access to medicines through
far-reaching programs that not only donate Merck medicines but help
deliver them to the people who need them. Merck also publishes
unbiased health information as a not-for-profit service. For more
information, visit www.merck.com.
Related Articles:
FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006 - February 24, 2006
FDA Advisory Committee Agrees that Clinical Data Support the Efficacy and Safety of Zostavax, Merck's Investigational Vaccine for Shingles, in Adults Aged 60 and Older - December 15, 2005
Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax - June 29, 2005
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