The US FDA has granted Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to scale-up the manufacturing process for gene therapy Adstiladrin (nadofaragene firadenovec) in Finland.
In December 2022, the US Food and Drug Administration (FDA) approved Ferring’s adenovirus vector-based gene therapy Adstiladrin, an intravesical therapy administered to the patient at three-month intervals.
The therapy is used to treat adults with high-risk Bascillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) that works by targeting the individuals’ bladder wall cells to boost the body’s natural defenses to fight cancer.
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The PAS approval will allow the firm to scale-up drug substance production process at FinVector Oy, located in Kuopio, Finland. This means the site will be available to be used as part of the planned product launch.
“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 NMIBC,” said Brent Ragans, US President, Ferring Pharmaceuticals.
FinVector began building the Adstiladrin dedicated Kuopio facility in May 2022 and said it will be one of the world’s largest viral vector manufacturing facilities. In addition to the Finland plant, Ferring is also constructing an FDA-approved manufacturing site in New Jersey to add further drug product capacity.
The Swiss firm anticipates that Adstiladrin will be commercially available in the US during the second half of 2023, with supplies for patients needing the treatment increasing into 2024.
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