Following a more than two-month delay to its PDUFA action date, Valneva’s chikungunya vaccine Ixchiq has won the regulatory race beating biotech Bavarian Nordic.
Pictured: Exterior of an FDA building/iStock, Grandbrothers
The FDA on Thursday approved Valneva’s chikungunya vaccine Ixchiq, beating the competition and becoming the first vaccine to secure regulatory approval to prevent the disease caused by the virus, according to the company’s announcement.
The vaccine is okayed for people 18 and older at increased risk of exposure to the mosquito-borne chikungunya virus. According to Valneva, the virus is “an emerging global health threat” with five million cases of chikungunya infection reported in the past 15 years, with the highest risk areas being parts of the Americas, Southeast Asia, and Africa—while spreading to new regions around the world.
“We aim to deliver vaccines in areas of unmet medical need, supporting our vision to contribute to a world in which no one dies or suffers from a vaccine preventable disease. As such, today marks an important step forward in the prevention of chikungunya,” Valneva CEO Thomas Lingelbach said in a statement.
In June 2023, Valneva presented data from its Phase III for the Ixchiq vaccine in which it demonstrated seroprotection rates of 98.6% in patients aged 18 to 64 years and 100% in patients 65 and older. The FDA granted the vaccine an accelerated approval pathway and Fast Track and Breakthrough Therapy.
However, it has not always been smooth sailing for Valneva’s Ixchiq. In August 2023, the FDA delayed the vaccine’s PDUFA date until the end of November to allow for more time to agree on a Phase 4 program, but no further clinical data was required.
The announcement of Thursday’s FDA approval has given a bump to Valneva’s stock price, rising over 6% yesterday and another 4% before the opening bell.
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions. Today’s approval addresses an unmet medical need and is an important advancement in the prevention of a potentially debilitating disease with limited treatment options,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
At the same time, the FDA’s approval announcement noted that while the vaccine was being examined chikungunya-like adverse reactions were reported, although it was not expected. Medical intervention or the “prevention of daily activity” was seen in 1.6% of Ixchiq patients, with two hospitalized. Others faced chikungunya-like adverse reactions that lasted for at least 30 days. The FDA is requiring Valneva to conduct a postmarking study to examine the risk of these adverse reactions.
Danish biotech Bavarian Nordic in August 2023 posted positive Phase III results for its chikungunya vaccine. That vaccine managed to show that it was capable of producing chikungunya-inducing antibodies in 98% of patients. However, Valneva beat Bavarian Nordic in getting FDA approval for its vaccine.
Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.
