RotaTeqTreatment for Rotavirus Gastroenteritis
Merck Announces that FDA Has Accepted For Review Biologics License Applications for Rotateq and Zostavax
WHITEHOUSE STATION, N.J., June 29, 2005 - Merck & Co., Inc. announced today that the Food and Drug Administration has accepted for review the Biologics License Applications (BLAs) for two investigational vaccines, Rotateq (rotavirus vaccine, live, oral, pentavalent) and Zostavax (zoster vaccine live (Oka/Merck)).
Rotateq is Merck's investigational pentavalent vaccine to protect against rotavirus gastroenteritis. Rotateq is an oral, liquid vaccine that contains five human serotypes: G1, G2, G3, G4 and P1. These five serotypes cause most rotavirus disease worldwide. Merck submitted the application for Rotateq to the FDA on April 5. Merck has also submitted applications for licensure of Rotateq in Australia, the European Union (EU) and Mexico, and plans additional filings later this year in Canada and in countries in Asia and Latin America.
Zostavax is Merck's 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 to the FDA on April 25. Merck has submitted an application for licensure of Zostavax in the EU, and plans additional filings later this year in Australia, Canada and in countries in Asia and Latin America.
Merck's BLA for Proquad (Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live) is under review by the FDA. Proquad is Merck's investigational vaccine for simultaneous vaccination against measles, mumps, rubella and varicella.
Merck remains on track to submit a BLA to the FDA for Gardasil, the company's investigational HPV and cervical cancer vaccine, in the second half of this year.
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, please visit the Merck website.
Posted: June 2005
- RotaTeq Approved - Merck & Co., Inc. - Treatment for Prevention of Rotavirus Gastroenteritis - February 3, 2006
- FDA Vaccines Advisory Committee Unanimously Agrees that Clinical Data from 70,000-Infant Phase III Trials Support the Efficacy and Safety of Rotateq, Merck's Investigational Vaccine for Rotavirus Gastroenteritis - December 14, 2005
- Merck Submits Biologics License Application to FDA for Rotateq, an Investigational Vaccine for Rotavirus - April 11, 2005