Amgen Sues the FDA Over Marketing Exclusivity for Sensipar in Pediatric Patients

Amgen is suing the FDA, requesting that its Sensipar medication be granted six additional months of pediatric market exclusivity after it completed three of four pediatric clinical trials requested by the agency.

The FDA formally denied the extra exclusivity based on the company’s failure to complete the remaining study. In its complaint, filed this week in the Washington, D.C. federal district court, Amgen argues it met the requirements under the law and it only needs to “fairly respond” to the FDA’s requests.

Sensipar (cinacalcet) was first approved in 2004 to lower the amount of calcium in the blood. It is used by long-term dialysis patients with chronic kidney disease and secondary hyperparathyroidism. In 2010, the FDA made a written request for four studies in similar patients under age 18.

The FDA placed a partial clinical hold on the program in February 2013, following the death of a patient in one of the clinical trials, in patients age 6 to 18.