NPS Pharmaceuticals, which is in the process of being acquired by Shire, has been boosted by the news that the US Food and Drug Administration has approved Natpara for hypoparathyroidism.

Specifically, Natpara (recombinant human parathyroid hormone) has got the green light to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects 60,000 people in the USA.

Hypoparathyroidism is also associated with long-term complications such as kidney damage, kidney stones, development of cataracts and calcification of soft tissues. Jean-Marc Guettier,  director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said the product, a once-daily injection, offers an alternative for patients whose calcium levels cannot be controlled on supplements and active forms of vitamin D.

Natpara carries a boxed warning that bone cancer has been observed in rat studies and it is only available through a restricted risk evaluation and mitigation strategy programme.

Shire is buying NPS in a deal worth $5.2 billion and the former’s chief executive, Flemming Ornskov, said the approval further validates  its decision to acquire NPS “which is an excellent strategic fit allowing us to leverage our  market expertise, core capabilities in rare disease patient management and global footprint”. The purchase is expected to close during the first quarter.