DC District Court Rules in Favor of FDA in Amgen Pediatric Exclusivity Case

Regulatory NewsRegulatory News | 21 February 2018 |  By 

For the second time in the last month, the District of Columbia's District Court took the US Food and Drug Administration's (FDA) side in the agency's decision to deny a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet).

In the earlier opinion and order, the court granted FDA summary judgment on all but one of Amgen's claims: that the agency's denial of pediatric exclusivity for Sensipar was inconsistent with its decision to grant pediatric exclusivity for Johnson & Johnson's drug Ortho Tri-Cyclen.

The court had asked FDA to explain its prior decision to grant pediatric exclusivity for Ortho Tri-Cyclen and why it was consistent with its decision denying pediatric exclusivity for Sensipar.

And since that decision, FDA added new documents and explained how it applied the same standard to Sensipar and Ortho Tri-Cyclen.

The court "is now satisfied that the FDA has offered a reasoned—and reasonable—basis for distinguishing the Ortho Tri-Cyclen precedent," the decision from 17 February said.

Yale University's Collaboration for Research Integrity and Transparency fellow Jeanie Kim and faculty co-directors Amy Kapczynski and Joseph Ross wrote: "By ruling for the FDA, the judge preserved the agency's authority and discretion to make pediatric exclusivity determinations in a way that encourages clinically meaningful research."

In terms of when Sensipar generics may come to market, Bernstein biotech analyst Ronny Gal said in an investor note sent Wednesday that on 8 March, unless ordered otherwise by the courts, FDA will convert pending abbreviated new drug applications (ANDAs) to final approvals and Sensipar generics will be legally allowed to launch at risk.

However, he also noted that Amgen recently listed a formulation patent that will not expire until 2026 and the company sued the generic filers in December 2017.



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