- Ferring Pharmaceuticals said Monday the Food and Drug Administration has cleared it to scale up manufacturing of its new gene therapy for bladder cancer.
- The treatment, called Adstiladrin, was approved for a high-risk form of the cancer late last year. At the time, Ferring said it would need to ramp up manufacturing capacity before a launch in the second half of 2023.
- Clearance of a so-called “prior-approval supplement” will allow Ferring to stick to that plan and expand production at a newly built plant in Finland that the company said will be one of the world’s largest viral vector manufacturing sites. Another plant under construction in New Jersey could add near-term capacity, too.
Ferring’s Adstiladrin had been in development since 2011 and, with last year’s approval, is now on track for initial marketing.
The gene therapy treats a high-risk form of the most common type of bladder cancer, known as non-muscle invasive bladder cancer, or NIMBC, that is unresponsive to Bacillus Calmette-Guérin therapy. It uses an adenovirus vector to deliver a gene for the immune-stimulating protein interferon alfa-2b, administered once every three months via a catheter to the bladder.
But common to gene therapies are manufacturing hurdles and viral vector bottlenecks, even after the challenging development process.
Two years before Ferring won approval of the gene therapy, the FDA had rejected the drug due to issues with manufacturing. The company had to work with its partner FinVector in order to meet FDA standards. FinVector started construction of the new facility in Kuopio, Finland last year.
Ferring said supplies of Adstiladrin will increase in 2024 following the drug’s planned rollout in the second of half of this year.