Valneva Announces FDA Approval of Accelerated IXIARO® Vaccination Schedule
Saint Herblain (France), October 5, 2018 - Valneva SE ("Valneva" or "the Company"), a commercial stage biotech company focused on developing innovative lifesaving vaccines, announced today that the U.S. Food and Drug Administration (FDA) has approved an alternate IXIARO® immunization schedule of two doses administered seven days apart for adult travelers aged 18-65 years old. This accelerated schedule comes in addition to the previously approved schedule.
IXIARO® is the only Japanese encephalitis (JE) vaccine licensed and available in the United States (U.S.). The vaccine was approved with a two-dose primary immunization with the two vaccinations administered 28 days apart. The newly-approved accelerated vaccination schedule allows rapid immunization in adults with the two doses given seven days apart. This rapid schedule has already been approved and is used in Europe and Canada.
Franck Grimaud, Valneva's Chief Business Officer, commented, "Many people make their travel plans at the last minute, so being able to receive IXIARO®'s two shots within seven days makes it easier for travelers, ultimately enhancing the value proposition of our product. The U.S. is IXIARO®'s largest market and we expect that this new schedule will encourage more U.S. travelers to seek prevention against this devastating disease."
The FDA's revised schedule follows previous approvals by Health Canada and the European Medicines Agency, who authorized accelerated IXIARO® vaccination schedules for adult travelers in March 2018 and April 2015, respectively.
Valneva's Japanese encephalitis vaccine is indicated for active immunization for the prevention of the disease for people who travel to, or live in, endemic areas. It has received marketing approval in the U.S., Europe, Canada, Hong Kong, Singapore, and Israel under the trade name IXIARO® and in Australia and New Zealand where it is marketed as JESPECT®. It is the only vaccine available to the U.S. military for Japanese encephalitis. IXIARO® is approved for use in individuals two months of age and older in the U.S. and EU member states, Norway, Liechtenstein, Iceland, Singapore, Hong Kong, and Israel. In all other licensed territories, IXIARO®/JESPECT® is indicated for use in persons 18 years of age and above.
About Japanese Encephalitis
Japanese encephalitis is a deadly infectious disease found mainly in Asia. About 70,000 cases of JE are estimated to occur in Asia each year, although the actual number of cases is likely much higher due to underreporting in rural areas. JE is fatal in approximately 30 percent of those who show symptoms, and leaves half of survivors with permanent brain damage. The disease is endemic in Southeast Asia, India and China, a region with a population of more than three billion. In 2005, JE killed more than 1,200 children in only one month during an epidemic outbreak in Uttar Pradesh, India, and Nepal.
About Valneva SE
Valneva is a fully integrated, commercial stage biotech company focused on developing innovative life-saving vaccines. Valneva's portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. The Company has various vaccines in development including a unique vaccine against Lyme disease. Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the US with over 450 employees. More information is available at www.valneva.com.
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