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FDA to review its pediatric exclusivity decision for Amgen's Sensipar

January 27, 2018 12:38 AM UTC

A federal judge ordered FDA to address whether its decision to grant pediatric exclusivity to Ortho Tri-Cyclen norgestimate/ethinyl estradiol from the Janssen Pharmaceuticals Inc. unit of Johnson & Johnson (NYSE:JNJ) is consistent with its decision to deny the same exclusivity to Sensipar cinacalcet from Amgen Inc (NASDAQ:AMGN). The court ordered the agency to provide a "reasoned explanation" for any "disparate outcomes."

Amgen filed the lawsuit against FDA last May in the U.S. District Court for the District of Columbia to compel the agency to accept Amgen's pediatric study reports and grant pediatric exclusivity for hyperparathyroidism drug Sensipar. Earlier that month, FDA had issued a letter denying Amgen's request for pediatric exclusivity, as the company only completed three of four required trials because the incomplete study did not meet minimum enrollment requirements. Sponsors are eligible for such exclusivity if they conduct pediatric studies of drugs upon FDA request (see BioCentury Extra, May 30, 2017)...