The approval will enable the Swiss company to scale up its drug substance manufacturing process for ADSTILADRIN at FinVector located in Kuopio, Finland to initiate the planned product launch
ADSTILADRIN is approved to treat BCG- unresponsive NMIBC with CIS with or without papillary tumours. (Credit: Robina Weermeijer on Unsplash)
Swiss biopharmaceutical firm Ferring Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for Adstiladrin (nadofaragene firadenovec-vncg).
The approval will enable the Swiss company to scale up its drug substance manufacturing process for Adstiladrin at FinVector Oy located in Kuopio, Finland.
Adstiladrin is said to be the first and only FDA-approved intravesical gene therapy for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.
The company said that the supplies from the scale-up process produced at FinVector’s FDA-approved facility will be available as part of the planned product launch.
Ferring Pharmaceuticals US president Brent Ragans said: “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.”
Ferring Ventures subsidiary FinVector is a biopharmaceutical company that manufactures viral-based gene therapy products.
In May last year, FinVector initiated the construction of a viral vector manufacturing site in Kuopio, Finland.
Within Ferring’s FDA-approved production site at the Parsippany, New Jersey, US campus, a new facility for Adstiladrin is being built to increase short-term drug production capacity, Ferring Pharmaceuticals said.
FinVector board member Giuseppe Carloni said: “Viral-based gene therapies like Adstiladrin have great potential for the treatment of severe diseases, including cancers where there is a high unmet patient need.
“Our long-established depth of expertise positions FinVector to remain at the forefront of pioneering the development and manufacture of new precision medicines.”
The US health regulator approved Adstiladrin in December last year to treat adult patients with high-risk BCG- unresponsive NMIBC with CIS with or without papillary tumours. The drug is administered via catheter directly into the bladder once every three months.
The Swiss company claimed gene therapy as an alternative to invasive bladder removal surgery.
Ferring plans to launch Adstiladrin in the US in the second half of 2023 as part of a targeted rollout, with supplies increasing in 2024.