26th Jan 2015 07:28
LONDON (Alliance News) - Shire PLC Monday noted that NPS Pharmaceuticals Inc, which Shire is acquiring, has had its Natpara drug for hypoparathyroidism approved by the US Food and Drug administration, saying it was further evidence of the value of the deal.
The US FDA has approved Natpara as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism, which is a rare endocrine disorder characterized by insufficient levels of parathyroid hormone.
"The Natpara label is in line with our expectations, and we believe this approval further validates Shire's decision to acquire NPS Pharma, which is an excellent strategic fit allowing us to leverage our market expertise, core capabilities in rare disease patient management, and global footprint, Shire Chief Executive Flemming Ornskov said in a statement.
Shire said it hopes to be able to launch the treatment in the US once its acquisition of NPS Pharmaceuticals closes during the first quarter of 2015.
The company also announced that its SHP609 compound for the treatment of neurocognitive decline associated with Hunter syndrome has been granted a fast track designation by the US Food and Drug Administration.
The fast track designation is intended to expedite the review of drugs, increasing the likelihood of the compound to be eligible for priority review.
By Steve McGrath; [email protected]; @stevemcgrath1
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