EMA grants Bavarian Nordic’s respiratory treatment access to priority medicines scheme

pharmafile | June 28, 2022 | News story | Manufacturing and Production  

The EMA has granted access to its priority medicines (PRIME) scheme for MVA-BN RSV in the active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by Respiratory Syncytial Virus (RSV) in adults under 60 years of age.

There are currently no approved vaccines for RSV, and access to PRIME has been granted upon an assessment that the available clinical data overall show the potential of MV-BN-RSV to address the unmet medical need in the proposed target population.

RSV is a common virus that typically causes mild, cold-like symptoms, but in severe cases can lead to lung infections like bronchiolitis and pneumonia, which can lead to death. The most vulnerable individuals include infants and the elderly/immunocompromised. It is estimated that each year RSV-induced infections lead to approximately 177,525 hospitalisations, and 14,000 deaths in adults aged 65 years and older in the US, similar to influenza.

Paul Chaplin, President and CEO of Bavarian Nordic, said: “Following the grant of a Breakthrough Therapy Designation from the US FDA earlier this year, we are proud to receive eligibility for PRIME access for our RSV vaccine candidate, enabling us to pursue accelerated development and review processes with the regulatory authorities in both US and Europe.

“These grants highlight the potential of our vaccine to fulfil the significant unmet need for a preventative therapy, particularly for the elderly who may be at risk from serious complications from RSV. As we continue the enrolment into the global Phase III trial of the vaccine, we look forward to working closely with both EMA and the FDA on accelerating the pathway towards approval.”

Lina Adams

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