Ixchiq FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 13, 2023.
FDA Approved: Yes (First approved November 9, 2023)
Brand name: Ixchiq
Generic name: chikungunya vaccine, live
Dosage form: Injection
Previous Name: VLA1553
Company: Valneva USA, Inc.
Treatment for: Chikungunya Disease Prevention
Ixchiq (chikungunya vaccine, live) is a live-attenuated, single dose vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.
- This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory studies.
- Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes. Symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia.
- Ixchiq is a live-attenuated vaccine that has been designed by deleting a part of the chikungunya virus genome. The exact mechanism of protection has not been determined. Ixchiq elicits CHIKV-specific immune responses.
- Pivotal Phase 3 data for Ixchiq published in the Lancet in June 2023 showed a 98.9% seroresponse rate at 28 days with a single vaccination. Ixchiq-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination. Valneva will continue to evaluate antibody persistence for at least five years.
- Ixchiq is administered by intramuscular injection.
- Warnings and precautions associated with Ixchiq include severe or prolonged chikungunya-like adverse reactions, vertical transmission of wild-type CHIKV from pregnant individuals with viremia at delivery causing potentially fatal CHIKV disease in neonates, and syncope associated with the administration of the vaccine.
- Common systemic adverse reactions include headache, fatigue, myalgia, arthralgia, fever, and nausea. Common local adverse reactions include injection site tenderness.
Development timeline for Ixchiq
Further information
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