Ferring Pharmaceuticals has been granted approval by the US Food and Drug Administration (FDA) for its ADSTILADRIN intravesical gene therapy manufacturing process. The drug is used to treat non-muscle invasive bladder cancer in adult patients with high-risk Bacillus Calmette-Guérin-unresponsive carcinoma in situ with or without papillary tumors. Ferring intends to make ADSTILADRIN available as part of an initial US rollout in H2 2023, with supplies increasing into 2024. Two new manufacturing sites are under construction in Finland and the US that will be dedicated to ADSTILADRIN. One of these sites will be one of the world's largest viral vector facilities.
Keywords: Ferring Pharmaceuticals, US FDA, approval, drug substance manufacturing, scale-up process, gene therapy, ADSTILADRIN, nadofaragene firadenovec-vncg
Ferring Pharmaceutical's intravesical gene therapy treatment for non-muscle invasive bladder cancer has received approval from the FDA for its manufacturing process. The company plans to roll out the treatment in H2 2023 after two new production sites have been completed. One of these facilities will be among the world's largest viral vector factories.