Ferring Pharmaceuticals has finally gotten FDA approval for its gene therapy medication Adstiladrin, a therapy used to treat bladder cancer patients. The medication is approved for the treatment of high-risk and non-muscle invasive Bacillus Calmette-Guérin (BCG)-resistant bladder cancer with carcinoma in situ and papillary tumours.
The company conducted a clinical research test in which 157 patients participated to evaluate the safety and effectiveness of the medication.
The FDA has provided data supporting the medication, stating that more than half of the patients who received the medicine experienced a full recovery. Adstiladrin is a treatment solution for patients who are at their last stage of illness, where the last resort is to undergo bladder removal. The therapy is injected into the patient’s bladder once every three months.
The medication has shown to successfully produce a protein in the body of the patients which fights against cancer. There are very few cancer treatments available on the market, and Adstiladrin is being considered as a viable option.
The journey of the FDA approval of Ferring’s medication was not easy despite strong results and data backing. The FDA denied the medication in May 2020, citing unanswered queries for the company’s manufacturing partner.
According to the CSO of Ferring, Armin Metzger, the company has collaborated with its partner and the FDA to align the production process with the demands of the organization. A company representative claims that Adstiladrin’s production method is difficult and lengthy compared to other options in the market. The business collaborates with FinVector, a Finnish manufacturing partner. According to Metzger, Ferring is also seeking to increase its own capacity at the same time.
Previously, Ferring split out the medication into a different business named FerGene. But when FerGene ceased operations, Ferring gained ownership of the gene treatment. Beyond this initial application for bladder cancer, Ferring will look at further indications for its gene therapy technology.
The decision comes after Ferring recently received another FDA approval of the first faecal microbiota product, Rebyota, to treat Clostridium difficile infections. Ferring acquired Rebiotix in 2018, which subsequently led to the acquisition of its therapy.
“Two approvals in a short period of time is amazing” for a business of Ferring’s scale and gives us a positive vision into the future.”
The company has stated that the cost of the medication cannot be disclosed and that it was too early to comment on it, but it is anticipated that the medication would be sold at a broader scale to increase availability to patients.
A report published in 2021 by the Institute for Clinical and Economic Review, which conducts research on the pricing of medicine claims that patients find the medicine value for money when it is priced between $158,600 and $262,000.