- The FDA rejected Eagle Pharma's request for orphan-drug exclusivity for its leukemia drug Bendeka, the company said earlier this week. The agency had approved the drug for treatment of chronic lymphocytic leukemia and a certain type of lymphoma in December 2015 under an orphan drug designation. However, it decided against giving Bendeka the seven years of orphan drug exclusivity.
- Eagle Pharma believed it was automatically entitled to the grant of exclusivity upon approval, and is examining its options for challenging the FDA's decision.
- Oprhan designation is granted for drugs developed to treat a rare disease, defined as affecting fewer than 200,000 people in the U.S.
The FDA currently requires sponsors of some drugs to demonstrate clinical superiority over existing drugs with the same indication in order to obtain seven years of exclusivity.
Eagle Pharma said it believed the FDA improperly rejected its request for exclusivity, citing a September 2014 case. In that case, the drugmaker DepoMed successfully challenged the FDA's decision to not grant seven years exclusivity for its drug Gralise. It argued an orphan drug designation automatically conferred exclusivity upon approval under the terms of the Orphan Drug Act. As Gralise had previously been designated, DepoMed said it did not have to prove clinical superiority.
Eagle Pharma views its current situation as similar to DepoMed's case. However, as it has existing patents running through 2033, Eagle CEO Scott Tariff believes the FDA's decision won't impact Bendeka in the near term.
Bendeka is being distributed via Teva as part of its oncology portfolio. Eagle receives 20% of proceeds from sales.