In an 8-5 vote, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of recombinant human parathyroid hormone (rhPTH[1-84]) for long-term treatment of hypoparathyroidism, according to a press release from NPS Pharmaceuticals.
rhPTH(1-84), which, if approved, would be marketed as Natpara, is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH). The treatment has received orphan drug status from the FDA.
During the meeting, the panel discussed data from the Natpara clinical development program. This included a pharmacology study and four safety and efficacy studies, including REPLACE, a pivotal phase 3, randomized, double blind, placebo-controlled study, according to the release.
“As a bioengineered replacement therapy targeting the underlying cause of the disorder, Natpara has been shown in clinical studies to maintain serum calcium while demonstrating similar physiologic effects to the native parathyroid hormone,” Francois Nader, MD, president and CEO of NPS Pharmaceuticals, said in the release.
“We look forward to working with the FDA to complete the final stages of review for our [Biologics License Application] for Natpara.”