Amgen has filed a federal lawsuit seeking to reverse FDA’s decision denying the drugmaker the standard six months of pediatric exclusivity for its marketed drug, Sensipar.
Amgen submitted data from four required pediatric studies, and five additional studies, to the FDA in November 2016. However, according to the FDA, in one of the studies, the drugmaker only had 11 patients enrolled for at least 12 weeks rather than the minimum 15 patients treated for 26 weeks requested by the agency.
The study initially had 18 patients but was placed on clinical hold after a patient death. During the hold, six patients left the study. Only four patients met all study completion criteria.
Pediatric exclusivity for a new indication would delay generic competition for Sensipar, a blockbuster drug used to treat secondary hyperparathyroidism (HPT).