Dive Brief:
- As Shire gets close to completing its $5.2 billion acquisition of NPS Pharma, the FDA's approval of NPS's Natpara (recombinant human parathyroid hormone) bodes well.
- Natpara is intended for treatment of hypocalcemia in patients with hypoparathyroidism, which affects roughly 60,000 people in the U.S.
- Natpara's approval comes with a black box warning due to the occurrence of Natpara-related bone cancer in rats in preclinical studies.
Dive Insight:
Approval of Natpara provides an important treatment option for patients with hypocalcemia secondary to hypoparathyroidism. Some complications associated with untreated hypocalcemia include kidney damage, kidney stones, development of cataracts and calcification of soft tissue.
Shire is certainly breathing a sigh of relief, as the company's decision to acquire NPS has been perceived as a risky bet by some industry observers. The company has been pursuing an acquisition strategy to bolster its rare diseases portfolio ever since its failed mega-merger with AbbVie.