Hypoparathyroidism

For those with hypoparathyroidism:

FDA Advisory Committee Recommends Approval of Natpara® for Long-Term Treatment of Hypoparathyroidism -

NPS Pharmaceuticals, Inc., a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted 8 to 5 that the available data support the approval of Natpara® (rhPTH [1-84]) for the long-term treatment of Hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone, or PTH. The Committee's recommendation will be considered by the FDA in its review of the company's Biologics License Application (BLA) for Natpara, which has a Prescription Drug User Fee Act (PDUFA) date of October 24, 2014.

Natpara is a bioengineered replacement therapy for endogenous PTH that NPS Pharma has developed for the treatment of Hypoparathyroidism. The FDA has granted orphan drug status for Natpara for the treatment of Hypoparathyroidism. The European Medicines Agency has also granted orphan drug status for the drug under the trade name Natpar™.

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  • Thanks, Hypnoteq. The news has pleased one hypoparathyroid patient who's existing meds aren't satisfactory. I wonder how long the approval process will take?

  • Hi Clutter. I hoped someone might find the information useful.

    I am a member of Climb which is for children's metabolic disorders and it came in their newsletter today, so I know no more than that unfortunately. It might be worth a wider Google though.

  • Hypnoteq, I tweeted it to Lorraine Cleaver who's hypoP. I should think she'll follow up on it but I imagine it'll take a considerable time to get approval and get the drug out there and then get NICE approval.

  • Yes, I should imagine it won't be a speedy process Clutter, but I know that CLIMB has powerful connections and alliances, and whether they will be particularly championing the cause, I dont know. Let's hope so.

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