The US FDA has approved NPS’ hypoparathyroidism drug Natpara, one of the main draws behind Shire’s $5.2bn takeover deal for the US pharma company earlier this month.
The US drugs regulator approved Natpara (recombinant parathyroid hormone) to treat low blood calcium levels – alongside calcium and vitamin D supplementation – in patients with the rare endocrine disease, which is caused by low levels of parathyroid hormone.
NPS chief executive Francois Nader said the company is “very pleased to offer the first and only parathyroid hormone approved for people living with this rare disorder.”
Shire announced its acquisition offer for NPS earlier this month, with some commentators expressing surprise that the company had gone public with its intentions so soon before the FDA was due to deliver a verdict on Natpara, although the drug successfully passed an advisory committee vote last September.
“People with hypoparathyroidism have limited treatment options and face challenging symptoms that can severely impact their quality of life,” said Jean-Marc Guettier, who heads the FDA’s division of metabolism and endocrinology products.
“This product offers an alternative to patients whose calcium levels cannot be controlled on calcium supplementation and active forms of vitamin D,” he added.
A clinical trial of Natpara demonstrated that 42% of Natpara-treated participants achieved normal blood calcium levels on reduced doses of calcium supplements and vitamin D, compared 3% of those on placebo.
Natpara is NPS’ second approved product after Gattex/Revestive (teduglutide), a GLP-2 analogue used for the long-term treatment of short bowel syndrome in adults that is expected to reach $350m in sales at peak. Natpara is considered to have greater peak sales potential however, with some analysts suggesting it could top $1bn by 2025 while others are more conservative and suggest $650m is a more realistic figure.
“The Natpara label is in line with our expectations, and we believe this approval further validates Shire’s decision to acquire NPS Pharma,” said Shire’s chief executive Flemming Ornskov in a statement.
“We look forward to combining our strengths with NPS Pharma to launch Natpara in the US after the expected close of the transaction in Q1 of this year,” he added.
Meanwhile, NPS’ application for the drug was accepted last month for review by the European Medicines Agency (EMA). If approved, the drug will be sold in the EU as Natpar.