Valneva nabs EU backing for Chikungunya vaccine

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.