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Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.
Amgen filed a complaint against FDA claiming the agency unlawfully denied the company pediatric exclusivity for its secondary hyperparathyroidism treatment Sensipar.
Amgen is back in court-and this time it’s suing FDA. Amgen filed a complaint, posted on FDA Law Blog, on May 25, 2017 after FDA denied the company six months of pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA), for its secondary hyperparathyroidism treatment Sensipar (cinacalcet).
In 2010, FDA requested Amgen conduct studies with Senispar in pediatric patients on dialysis with chronic kidney disease and secondary hyperparathyroidism. Amgen submitted data from the requested studies to FDA; however, on May 22, 2017 the agency denied Amgen’s request for pediatric exclusivity.
FDA cited issues with Study 3 as a reason for denying pediatric exclusivity. Study 3 involved patients between the ages of 28 days and six years; which, at the time, was only 300 patients nationwide. Amgen said it had difficulty recruiting patients for Study 3 and only four patients saw the study to completion-a mere 27% of the 15 patients requested by FDA.
Amgen stated in the complaint that some of the difficulty with recruitment was related to a 14-month clinical hold placed on the studies by FDA after a fatality was reported in another pediatric Sensipar study. “The clinical hold made an almost impossible task actually impossible,” Amgen wrote in its complaint to the court.
Now Amgen wants FDA to vacate its decision, accept the study reports, and grant exclusivity. The company argues that FDA is not permitted to “assess the sufficiency of data in determining whether to accept pediatric studies.” The agency must only determine if the “studies ‘fairly respond’ to the written request.”
“FDA’s denial of pediatric exclusivity reflects an abrupt and unexplained departure from the agency’s past treatment of similarly situated entities,” Amgen wrote. “To the best of Amgen’s knowledge, FDA previously has determined that a sponsor’s failure to meet a single requirement of the written request-including the number of patients completing one study-does not mean the submitted studies do not ‘fairly respond’ to the agency’s written request.”
The company’s patent for Sensipar is set to expire in March 2018. This is far from Amgen’s first patent lawsuit. The company has filed several patent infringement complaints, including a recent lawsuit against Sanofi/Regeneron involving Amgen’s patent for IL-4 inhibitors.
Source: FDA Law Blog