- Eagle Pharmaceuticals last week sued the Food and Drug Administration over the agency's denial of marketing exclusivity for Bendeka, a cancer treatment from Eagle which won approval in December 2015.
- Although the FDA had granted an orphan drug designation for Bendeka prior to approval, it denied Eagle the seven years of marketing exclusivity typically given to orphan drugs. Eagle claims the FDA acted unlawfully, citing a similar 2014 case involving DepoMed.
- At issue is whether or not Eagle must demonstrate Bendeka's clinical superiority in order to win the period of exclusivity. In the DepoMed case, the judge ruled the FDA must grant exclusivity to any drug it designates as an orphan drug and subsequently approves. The FDA, however, argues drugs must also be clinically superior to existing treatments (if they exist).
When the FDA first denied orphan drug exclusivity on Bendeka in March, Eagle said it believed the FDA's decision to be incorrect and that it was automatically entitled to the exclusivity period. It has now followed that up with a lawsuit in the U.S. District Court for the District of Columbia, the same court which ruled against the agency in 2014.
In that case, Judge Ketanji Brown Jackson ruled the Orphan Drug Act required the FDA to recognize the exclusivity period for DepoMed's drug Gralise, which had also been approved but not granted exclusivity. Following the ruling, Gralise was subsequently awarded the seven years of exclusivity.
But the FDA disagreed with Judge Jackson's finding and has continued to ask for a demonstration of clinical superiority.
With Eagle's Bendeka, the situation has now repeated itself. "[Bendeka] was designated by FDA as an orphan drug in 2014 and received FDA approval in 2015, but FDA has nevertheless unlawfully denied Bendeka its statutorily mandated exclusivity," said Eagle in the complaint.
Eagle is seeking the full seven years it believes the law requires the FDA to grant, and also wants an enjoinment that no other drugs covered by Bendeka's orphan drug designation be approved during that period.
And although Bendeka has the same active pharmaceutical ingredient as Teva's Treanda, Eagle also claims its improved formulation makes the drug demonstrably superior.
The FDA took a hard line in disagreeing with the 2014 decision, so this case could prove an important test of the agency's regulatory powers under the Orphan Drug Act. As for Eagle, it is confident the six patents on Bendeka will protect the drug from competition through 2033 regardless of the ultimate decision.