FDA approved natpara, a rare disease drug of NPs, and shire acquired the first harvest

Source: Biovalley 2015-01-27 January 27, 2015, after a long time of trade-offs, the US FDA recently officially announced the approval of the listing of natpara, a rare disease drug developed by NPs The injection drug is mainly used to replace human parathyroid hormone to treat a rare endocrine disorder called hypoparathyroidism The disease can lead to calcium deficiency and vitamin D synthesis obstruction, and eventually lead to complications including muscle pain, bone density problems and so on In some acute cases, it may even lead to arrhythmia Natpara's road to declaration is a lot of twists and turns First, the FDA extended the review time of its first experimental data to three months, and then the expert committee under the FDA challenged the biomarkers used in the drug research What's more, some experts point out that animals treated with the drug in preclinical studies have leukaemia symptoms All of these cast a shadow over natpara's future Even if the expert committee finally approved the drug by a small margin of 8:5, experts still pointed out that the drug was not satisfactory in improving bone mineral density and reducing urinary calcium content However, the FDA finally chose to pass the drug The main reason is that there are 60000 patients with hypoparathyroidism in the United States There is no effective treatment plan for these patients Compared with other treatment options, natpara can significantly increase the blood calcium concentration of patients, the FDA said FDA requires NPs to sell natpara with a risk of leukaemia The final approval of natpara made shire the winner Shire acquired NPs for $5.2 billion earlier this year to expand its capabilities in rare disease research Now, NPs has proved to it that the acquisition is worth the money It is understood that the acquisition will be formally completed in the first quarter of this year