Company reportedly on schedule to make drug available in the second half of this year.
Ferring pharmaceuticals, a biopharma organization, has announced the FDA approval on a Prior-Approval Supplement (PAS) to an initial Biologics License Application (BLA) for the intravesical gene therapy Adstiladrin (nadofaragene firadenovec-vncg). According to the company, this approval will enable an increase in manufacturing at the FinVector Oy facility located in Kuopio, Finland.
With supplies expected to increase in 2024, Ferring expects to start rolling out Adstiladrin in the second half of 2023.
“The FDA approval of this supplement is an important step in our manufacturing scale-up which highlights our continued commitment to bring Adstiladrin to the community and in helping patients who are suffering from non-muscle invasive bladder cancer,” said Brent Ragans, US President, Ferring Pharmaceuticals.
Reference: Ferring Pharmaceuticals Receives U.S. FDA Approval of Drug Substance Manufacturing Scale-up Process for Gene Therapy ADSTILADRIN® (nadofaragene firadenovec-vncg). June 12, 2023. Accessed June 20, 2023. https://www.businesswire.com/news/home/20230612641977/en/Ferring-Pharmaceuticals-Receives-U.S.-FDA-Approval-of-Drug-Substance-Manufacturing-Scale-up-Process-for-Gene-Therapy-ADSTILADRIN%C2%AE-nadofaragene-firadenovec-vncg
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