FDA rejects Eagle Pharma’s seven-year orphan drug exclusivity for Bendeka blood cancer drug

Bendeka (bendamustine hydrochloride injection, or bendamustine HCI) is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.

It was approved in December last year to treat patients with chronic lymphocytic leukemia and for the treatment of patients with indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.

For its latest denial, the agency cited the need for the company to demonstrate clinical superiority for Bendeka before receiving the seven-year exclusivity orphan drug status.

The requirement will be applied whenever the FDA has earlier approved another drug of the similar active moiety for the same indication.

Eagle believes that the FDA should grant exclusivity depending on orphan drug designation granted in 2014. The company is evaluating all options to challenge the agency’s decision.

Eagle Pharmaceuticals president and CEO Scott Tarriff said: "We are disappointed with the agency’s decision regarding orphan drug exclusivity for Bendeka, which we believe to be incorrect.

"With six Orange Book listed patents extending from 2026 through 2033, and additional pending patent applications, the market protection for Bendeka is likely to be intact for many years. These patents will continue to be in effect beyond the seven years of exclusivity that would have been provided had the orphan drug exclusivity been granted."