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The EU drug regulator, the European Medicines Agency (EMA), announced Friday that an expert panel of the agency backed Ixchiq, developed by French biotech Valneva (NASDAQ:VALN) to prevent adults from contracting Chikungunya, a mosquito-borne viral disease.
Issuing a so-called positive opinion, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorization to use the single-dose vaccine in adults aged 18 and older.
The CHMP recommendation, backed by data from a pivotal trial of 362 participants that indicated superior serological results for Ixchiq, will next be reviewed by the European Commission (EC) before a final decision on its marketing authorization. If approved, the live-attenuated vaccine will be the region’s first EU-authorized shot against Chikungunya.
However, the EMA said the company was requested to conduct a post-authorization trial to evaluate the vaccine’s efficacy in preventing Chikungunya in adults.
In November, the FDA approved Ixchiq as the world’s first Chikungunya vaccine.