FDA, seeking time for phase 4 talks, delays decision on Valneva's chikungunya vaccine by 3 months

The FDA is making Valneva wait. Two weeks from the original deadline, the agency has pushed back its decision on whether to approve Valneva’s chikungunya virus vaccine candidate by three months.

Valneva had expected to receive a decision on the candidate, VLA1553, by the end of the month. Now, the French biotech has revealed that the FDA has pushed back its decision date to the end of November. According to Valneva, the FDA needs more time “to align and agree on the phase 4 program necessary under the accelerated approval pathway.” The agency hasn’t asked for more clinical data.

In a statement, Juan Carlos Jaramillo, M.D., chief medical officer at Valneva, said that if VLA1553 is authorized it “will represent the first vaccine candidate to be approved under the accelerated approval pathway in an outbreak disease, and hence the necessary phase 4 activities will set a future standard.” 

“We believe it may be possible to obtain an approval before the new PDUFA date,” Jaramillo added.

Despite the delay, Valneva remains on track to be the first company to win approval for a chikungunya vaccine in the U.S. The developer of the first vaccine against the infectious disease will pick up a priority review voucher (PRV), a resource that can be used to accelerate a subsequent FDA review or sold. 

While Valneva is still in first place in the PRV race, the delay will eat into the time that it has the market to itself. Merck & Co. dropped out of the race earlier this year, but Bavarian Nordic, which has reported back-to-back phase 3 successes in recent weeks, remains in Valneva’s slipstream. 

Bavarian Nordic appears to be holding a strong hand. Since buying the candidate in a $380 million deal, the Danish drugmaker has presented clinical data that suggest, with the usual caveats about cross-trial comparisons, that its vaccine provides comparable protection to VLA1553 and may act faster. 

Shares in Valneva fell 11% to 6.04 euros ($6.60) in early trading on the Paris exchange Monday.