ZostavaxTreatment for Herpes Zoster -- Prophylaxis
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
WHITEHOUSE STATION, N.J., December 15, 2005 - Merck & Co., Inc. announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee agreed that the extensive data from clinical trials in more than 40,000 people support the efficacy and safety of Zostavax [zoster vaccine live (Oka/Merck)], the Company's investigational vaccine, to prevent shingles in adults aged 60 and over.
The Advisory Committee did not agree that the data presented were sufficient to support the efficacy and safety of Zostavax in adults aged 50 - 59 as the Company had proposed. The Advisory Committee also suggested areas for additional analysis. Merck plans to work with the FDA on these analyses as well as the design of Merck's already planned post-licensure studies.
The FDA is not bound by the committee's recommendation but takes its advice into consideration when reviewing investigational vaccines.
"Shingles can be a very painful disease that can lead to serious and long-lasting complications," said Peter S. Kim, Ph.D., president, Merck Research Laboratories. "We are pleased with today's outcome and look forward to working with the FDA as it continues its review of our application for this vaccine."
The company filed a Biologics License Application (BLA) with the FDA on April 25 for Zostavax to reduce the risk of shingles; to reduce the risk of postherpetic neuralgia, the persistent, often debilitating long-term nerve pain that is the most common complication of shingles; and to reduce the total burden of pain and discomfort caused by shingles.
In addition to the U.S. regulatory application, Merck has filed regulatory applications for Zostavax in several other world markets including the European Union, Canada and Australia.
Merck presented data from several studies conducted in more than 40,000 people, including data from the Phase III Shingles Prevention Study (SPS) of 38,500 adults age 60 and over. The SPS was a Department of Veterans Affairs (VA) study conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH) and Merck at 22 U.S. research sites over a period of five years. Results from the SPS were published in the June 2 issue of The New England Journal of Medicine.
About Shingles and Postherpetic Neuralgia
Shingles is caused by the reactivation of latent varicella zoster virus - the same virus that causes chickenpox. Shingles may first appear as abnormal skin sensations ranging from itching or tingling to severe pain on a single area of the body or face. It then usually progresses to a rash and fluid-filled blisters accompanied by pain in almost every case. The pain varies in intensity and duration. Shingles also can lead to severe complications, including long-term nerve pain (postherpetic neuralgia) that can follow an episode of shingles. This complication can last for months or even years after the rash has healed and can range from a tender, burning pain to a throbbing, stabbing pain.
Shingles can affect anyone who has had chickenpox -- more than 90 percent of adults in the United States -- and occurs most frequently in older adults. In fact, it is estimated that up to half of all people who reach age 85 will have developed shingles during their lifetime. A recent study estimated that up to 1 million cases of shingles occur every year in the United States. The number of shingles cases is expected to increase as the population ages.
Source: Merck & Co., Inc.
Posted: December 2005
- FDA Expands Indication for Zostavax, Merck's Shingles Vaccine, to Include Adults Ages 50 to 59 - March 25, 2011
- FDA Review Date for Merck's Investigational Shingles Vaccine Extended to May 25, 2006 - February 24, 2006
- Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax - June 29, 2005
- Merck Submits Biologics License Application to FDA for Zostavax, an Investigational Vaccine for Shingles and Shingles-Associated Nerve Pain - May 2, 2005
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