Court Rules FDA Must Grant Orphan Drug Exclusivity for Bendeka

In a second successful legal challenge of the FDA’s approach to orphan drug designations, a federal court ordered the agency to grant Eagle Pharmaceuticals orphan drug exclusivity for its cancer drug Bendeka.

The FDA rejected Bendeka (bendamustine hydrochloride), a leukemia and lymphoma chemotherapy infusion, for orphan drug status in 2016, saying the company did not prove clinical superiority to an approved drug. But Eagle responded with a lawsuit claiming the agency ignored a 2014 court ruling that ordered the FDA to grant exclusivity to Depomed’s pain drug Gralise (gabapentin) under almost identical circumstances.

The 2014 ruling in the case of Depomed v. HHS found that under the plain language of the Orphan Drug Act the FDA must recognize that any drug is entitled to an exclusivity period if it has been designated as an orphan drug for a qualifying condition or disease and also approved for marketing. Under the court’s interpretation, the FDA is only to serve in a ministerial role in the exclusivity process.