In an effort to enhance support for its development, the European Committee for Medicinal Products for Human Use (CHMP) granted priority medicine (PRIME) designation in September to a new chikungunya virus vaccine candidate developed by Emergent BioSolutions Inc.
“Emergent is pleased to receive this important EMA designation and encouraged by the strength of our early data package, including results from the interim analysis of our Phase 2 safety and immunogenicity study for our CHIKV VLP vaccine candidate announced last April,” Abbey Jenkins, senior vice president of vaccines business for Emergent, said.
Chikungunya is a mosquito-spread virus. Its effects include joint pain, headache, muscle pain, joint swelling, and rashes. The virus has spread to Africa, Asia, Europe, the Indian and Pacific Oceans and, most recently, in the Caribbean without any vaccine treatment.
“We are highly motivated to help address the significant unmet need presented by the chikungunya virus, considered a global threat due to the debilitating nature of the resulting illness and potential magnitude of its ability to spread,” Jenkins said. “We look forward to working with the EMA to execute on our development plan, which contemplates initiation of a pivotal trial in 2020.”
The candidate is a VLP, meaning a virus-like particle. It is already licensed through the National Institute of Allergy and Infectious Diseases as the National Institutes of Health and gained Fast Track designation from the U.S. Food and Drug Administration last year. With support from PRIME, the European Medicines Agency will help Emergent optimize development plans and speed up the evaluation process.