NPS Pharmaceuticals announced
that the U.S. Food and Drug Administration (FDA) has extended the company’s Prescription Drug User Fee Act (PDUFA) action date for Natpara’s Biologics License Application (BLA) by 3 months. The PDUFA date has moved from October 24, 2014 to January 24, 2015.
Natpara (rhPTH [1-84]) is a bioengineered replacement therapy for endogenous parathyroid hormone (PTH) for the treatment of hypoparathyroidism
According the NPS Pharmaceuticals, the extension is to “provide time for a full review of a major amendment.” The FDA has also requested that NPS Pharmaceuticals submit a Risk Evaluation and Mitigation Strategy (REMS) for Natpara. Additional clinical studies have not been requested.
Francois Nader, MD, president and chief executive officer of NPS Pharmaceuticals said:
“We continue to work closely with the FDA to finalize the review of our BLA for Natpara and appreciate the effective collaboration with the Agency to date.”
“We continue to advance our commercial readiness activities and are planning for the launch of Natpara in the second quarter of 2015.”
Last month, the the Endocrinologic and Metabolic Drugs Advisory Committee voted 8 – 5 in favor of the U.S. Food and Drug Administration (FDA) approving Natpara for the Hypoparathyroidism
Hypoparathyroidism is a rare endocrine disorder that can arise after removal or damage to the parathyroid glands during neck surgery. The subsequent reduced parathyroid hormone levels that in turn causes hypocalcemia. An estimated 60K-80K people have hypoparathyroidism and symptoms may include paresthesias, muscle spasmbs, tetany, back pain, muscle twitching, throat tightness, musculoskeletal pain, anxiety, and depression. The current treatment approach is calcium and vitamin D supplements but they do not treat the underlying cause of the problem whereas Natpara does. As we wrote recently
, patients with hypoparathyroidism are displeased with current treatment options.