Cinacalcet - USA

On Feb. 17, 2018, U.S. District Judge Randolph D. Moss of District of Columbia granted FDA’s renewed motion & denied pediatric exclusivity to Amgen’s Sensipar drug.

Amgen brought this action to challenge the decision of the Food and Drug Administration (“FDA”) denying Amgen pediatric exclusivity for its drug, Sensipar (cinacalcet hydrochloride). In an earlier opinion and order, the Court granted the FDA summary judgment on all but one of Amgen’s claims: its claim 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 [Amgen Inc. v. Hargan, --- F. Supp. 3d ---, 2018 WL 581006 (D.D.C. Jan. 26, 2018)]. As to that claim, the Court concluded that the FDA had failed to offer a “reasoned explanation” for why it reached a “disparate outcome” with respect to Ortho TriCyclen. On remand, the FDA reaffirmed its Sensipar decision and explained why, in its view, this result was consistent with its decision on Ortho Tri-Cyclen. The FDA issued an addendum to its Remand Decision, again concluding that its Sensipar and Ortho Tri-Cyclen decisions were not inconsistent. Amgen has now renewed its motion for summary judgment on the grounds that the FDA’s latest explanation is inadequate and that its denial of pediatric exclusivity for Sensipar thus remains arbitrary and capricious.

The FDA denied Amgen’s request for pediatric exclusivity for Sensipar because Amgen’s studies did not, in the agency’s view, “fairly respond” to the written request. According to the FDA, Amgen’s studies did not fully comply with the requirements of the written request: for one of the studies, the written request required a minimum of fifteen patients ages 28 days to < 6 years, but only four patients completed the study and in the FDA’s view, Amgen’s data did not yield “clinically meaningful” information on cinacalcet’s safety in that age group—a key objective of the written request. FDA granted exclusivity for Ortho Tri-Cyclen because the agency “decided” that the Ortho Tri-Cyclen studies, unlike the Sensipar studies, “met the enrollment criteria in the [written request] at the time of the [exclusivity] decision.”

Court held that in the FDA’s scientific judgment at the time of the relevant decisions, the Ortho Tri-Cyclen studies met the terms of the written request, and the Sensipar studies did not. Whether the FDA was, in fact, correct in determining that the Ortho Tri-Cyclen study subjects met the DSM-IV criteria is not the relevant question. All that matters for present purposes is whether the FDA applied an interpretation of “fairly respond” to Amgen that differed from the standard it applied to Johnson & Johnson, and the agency has reasonably explained that it did not do so. Court further held that Amgen has not met its burden of demonstrating that the FDA applied different standards. The Court, accordingly, satisfied that the FDA has offered a reasoned—and reasonable—basis for distinguishing the Ortho Tri-Cyclen precedent.

Applying these principles here, the Court concluded that the FDA has offered a reasoned explanation for why it reached different outcomes in response to the Ortho Tri-Cyclen and Sensipar applications for pediatric exclusivity. Thus For the reasons stated above, the Court DENIED Amgen’s renewed motion for summary judgment and GRANTED the FDA’s renewed motion for summary judgment.