Amgen on May 25 filed a lawsuit against the Food and Drug Administration after the agency denied the drugmaker a six-month exclusivity period for its secondary hyperparathyroidism treatment Sensipar, reports Life Sciences Intellectual Property.
Here are five things to know.
1. Seeking a six-month exclusivity period to use the drug to treat children, Amgen spent $10 to $15 million to conduct four pediatric clinical trials requested by the FDA.
2. Amgen sent trial data to the agency in November 2016. On May 22, the agency denied the drugmaker the exclusivity period since one of the clinical trials failed to meet the minimum number of patients required.
3. Amgen said the FDA placed a clinical hold on the trial following a patient death, which prevented the company from continuing study enrollment to meet the required number of participants, according to the report.
"Notwithstanding these challenges, Amgen made every effort to reach the target number of completing patients in study three," the drugmaker said in the suit. "The clinical hold made an almost impossible task actually impossible."
4. The lawsuit claims the FDA is required to accept study reports and grant the exclusivity period as long as the trials "fairly respond" to the agency's original written request, according to the report. The lawsuit alleges FDA's actions are in violation of the Administrative Procedure Act, which governs how federal agencies propose and establish regulations.
5. Amgen is calling on the federal court to vacate the FDA's original decision to deny exclusivity and require the agency to accept the drugmaker's clinical trial documents, according to the report.
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