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™.

[Clutter]

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?

[Hidden in reply to Clutter]

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.

[Clutter in reply to Hidden]

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.

[Hidden in reply to Clutter]

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.

[ranornan]

Hello thyroid sufferers,

Im replying to this thread, which is old, because I am on Natpara.

I had a TT two years ago. I had papillary thyroid cancer. It took 5 hrs to remove the cancer as it had attached to something in the back of my neck. Due to the prolonged surgery time it affected my parathyroids. I struggled with calcium problems for a year and a half. Finally I was put on Natpara. Ive been on it since April.

Im on 50 mcg of natpara injections a day

5 mcg of liothyronine a day

.15 mg of Synthroid a day

Iron as needed for severe anemia

B12 as needed for low levels

EGFR was at 60 due to para levels (this really scared me because the Dr said if I didn't go on Natpara I might experience kidney failure)

TSH suppressed so cancer will not return

As soon as I took Natpara I started hot flashes and stopped having a period

I also had low calcium symptoms less frequently, prior to natpara I was on 2000 mg of calcium a day Vit D ergo and calcitriol, yet still had hypocalcemia. Symptoms were heart palpitations, thumb cramping to palms of hands, tingling hands, feet and face, trouble breathing, teeth easily broken, and anxiety.

Now that Im on Natpara I do believe its lead to severe arthritis in my dominant hand. Swelling and trigger fingers have been experienced. But I will make the trade since my hypocalcemia was much more scary. I still experience hypocalcemia at times but only after bouts of digestive problems, leading me to the idea that its because Im not able to absorb it at times if I eat too much fiber or over load my kidneys if I drink more than one alcoholic beverage in a day. My hand cramps dissipate when I work, but come back with inactivity.

I write this because I tend to take every day one day at a time. My symptoms change on a dime and my body is not the same as prior to the surgery. I know my situation is unique, yet I also know there maybe some one suffering as I am and thinking they are alone. Im 44 and a single mother of two teens. I have a house cleaning job that is very physically taxing, yet I believe it is helping me get acquainted with my new limitations and it is helping me rebuild my bones after being so low in calcium after surgery. I had to change jobs 4 times after my surgery because I was suffering physically, yet had to keep supporting my family. I am also one of Jehovahs Witnesses, which is my absolute life support.

I am open to any questions if you have a sincere need, but please give me time to reply.