Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) has announced that the 11th Circuit Court of Appeals has issued a positive decision regarding the company’s appeal seeking to overturn the decision by the District Court that upheld the US FDA’s authorization of Ruzurgi.
Ruzurgi approval violated Catalyst’s exclusivity rights.
Ruzurgi is another amifampridine product the FDA approved for lambert-Eatin myasrthenuc syndrome treatment in pediatric patients despite an existing Orphan Drug exclusivity for the company’s Firdapse tablet 10mg. The 11th Circuit Court has reversed the District Court’s ruling and remand the issue to the District Court with directions for summary judgment for the company. The 11th Circuit Court’s ruling adopted the company’s main argument the Ruzurgi’s approval violated the company’s Orphan Drug rights exclusivity.
Catalyst CEO Patrick McEnany said, “We are extremely pleased with the 11th Circuit Court’s decision and are hopeful that it brings to a close this case that is not just important for Catalyst, but for all patients living with rare diseases who depend on medicines that would not be available if not for the efforts and investment of pharmaceutical companies willing to pursue these indications.”
Orphan Drug designation offers market exclusivity
McEnany further explained, “The purpose of the Orphan Drug Act is to encourage pharmaceutical companies to make the R&D investments necessary to bring FDA-approved therapies to patient populations living with very rare diseases, and the biggest incentive the Orphan Drug Act provides is the ability to have an exclusive market within that rare disease for their drug for seven years once they obtain approval. This decision increases the hope for the patients living with these diseases that one day soon an approved drug for their rare disease might be a reality. This is a goal that we feel we share with the FDA despite this dispute, and we look forward to working with the FDA in the future on these issues.”