Hot on the heels of dropping its cancer vaccine programme, Bavarian Nordic has secured a win in more familiar territory, after the big pharma received an accelerated assessment from the EMA for its chikungunya vaccine.
Bavarian Nordic said it aims to submit a marketing authorisation application to the agency in the first half of 2024 for its CHIKV VLP candidate. The accelerated assessment means that the EMA could review the application in 150 days, rather than the normal 210.
Accelerated assessments are issued to drug products of major public health and therapeutic innovation.
Bavarian Nordic’s CEO Paul Chaplin said that the company also plans to submit a biologics licence application (BLA) to the US Food and Drug Administration (FDA) later this year.
Chikungunya is a mosquito-borne disease that causes fever and severe joint pain. Death from the virus is rare, but joint pain can sometimes last up to months and is debilitating.
Bavarian Nordic’s CHIKV VLP has demonstrated positive results from two successfully completed Phase III trials which enrolled just over 3,500 health participants. Both studies met their primary endpoints of inducing high levels of neutralising antibodies against the disease after 22 days.
Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Company Profile – free
sample
Your download email will arrive shortly
We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form
By GlobalData
The trial in adolescents and adults aged 12 to 64 years (NCT05072080) showed that 98% of vaccines had antibodies while the trial in adults older than 65 (NCT05349617) had antibodies confirmed in 82% of individuals. Bavarian Nordic reported mild to moderate adverse events, with the most common being muscle pain, fatigue, and headache.
Valneva’s Ixchiq became the world’s first licensed chikungunya vaccine when it was approved by the FDA in November 2023. There is currently no vaccine approved for the disease in Europe, although Bavarian Nordic will have to catch up with Valneva who had a marketing application for its candidate accepted by the EMA under accelerated assessment in November 2023.
Bavarian Nordic, which reported its most successful financial year in 2023, recently streamlined its portfolio. The drugmaker shelved its immune-oncology project, which had a vaccine candidate dubbed TAEK-VAC-HerBy in a Phase I trial. While announcing financial results, Bavarian Nordic said the project had “reached a stage where clinical expansion and further investments would be required”.
The company redirected resources and R&D efforts to its infectious diseases programmes, the therapy area in which the big pharma has enjoyed success. Bavarian Nordic’s revenue jumped from a surge in sales of its Jynneos vaccine for smallpox / mpox along with its travel health range.
In May 2023, Bavarian Nordic strengthened its travel vaccine portfolio and acquired Emergent’s travel health business in a deal worth up to $380m.
Source link
#Bavarian #Nordics #chikungunya #vaccine #secures #EMA #fasttrack
