A federal judge ruled that the U.S. Food and Drug Administration acted reasonably in deciding not to grant pediatric exclusivity to Amgen Inc.'s kidney drug Sensipar.
Sensipar is meant to treat secondary hyperparathyroidism, which can lead to bone fractures and deformities. The drug is already approved for adults and was prescribed off-label to the pediatric population, prompting the FDA to ask the company to investigate it in that population.
The drug has generated $1.72 billion of sales for Amgen in 2017.
The U.S. FDA is required to grant six months of additional market exclusivity and patent protection to drugs for which pediatric studies have been requested. However, the regulator denied exclusivity after Amgen failed to enroll the required number of patients in the study.
In 2017, the company filed a lawsuit against the agency, alleging that it unlawfully denied a six-month period of marketing exclusivity for pediatric uses of the drug. It argued that it was unable to find enough candidates due to a lower patient population and that its study data be considered "fair" given the circumstances.
Amgen also contended that the agency's actions were inconsistent with its earlier decision to grant Johnson & Johnson pediatric exclusivity for its oral contraceptive Ortho Tri-Cyclen.
U.S. District Judge Randolph Moss rejected the contention saying the company failed to prove that the agency applied different standards. In addition, the court is satisfied that the FDA has offered a reasonable basis for the differentiation relating to Ortho Tri-Cyclen.
On the company's latest earnings call, Anthony Hooper, Amgen's executive vice president of global commercial operations, said "the 2018 outlook for Sensipar is somewhat uncertain given the ongoing litigations."
"It is of course conceivable that competitors may be able to bring generic products to market at some point in 2018, although we believe we have strong litigation positions," Hooper said.