Support and Resources

Dr. Warren:
YORVIPATH, when in the body, undergoes cleavage of the linker, depending on physiological pH and temperature.

The now released active PTH, then goes on to the PTH receptor to exhibit its effects, and the remaining carrier and linker then undergo renal clearance. YORVIPATH is designed to provide continuous exposure to active PTH over 24 hours, allowing for once-daily dosing.

It is important to note that the active PTH release from YORVIPATH has an apparent half-life of approximately 60 hours.

Dr. Warren:
The Phase 3 trial for YORVIPATH involved a multi-component efficacy assessment.

In order to count towards this efficacy assessment, patients had to achieve all the following: albumin-corrected serum calcium levels in the normal range, independence from conventional therapy, no increase in the study drug dose since Week 22, no missing active vitamin D or calcium data since Week 22, study drug dose of ≤30 mcg per day during the entire 26-week treatment period.

And at Week 26, 68.9% of patients taking YORVIPATH achieved this multi-component efficacy assessment and met all these individual criteria, compared to only 4.8% of patients taking placebo.

When we take a closer look at the results for the individual efficacy components, 86.9% and 95.1% of patients taking YORVIPATH achieved independence from therapeutic doses of calcium and active vitamin D, respectively, compared with 4.8% and 23.8% of patients taking placebo. 80.3% of patients taking YORVIPATH achieved normal albumin-corrected serum calcium compared with 47.6% taking placebo. In 93.4% of patients taking YORVIPATH had no increase in study drug dose compared with 57.1% of patients taking placebo. Lastly, regarding the dosing of YORVIPATH, 91.8% of patients maintained a YORVIPATH dose of ≤30 mcg per day up to Week 26.

As for the continued efficacy shown by YORVIPATH, 39.3% of YORVIPATH-treated patients met the multi-component efficacy assessment at both Week 52 and Week 78. However, when allowing for physicians to up titrate the dose of YORVIPATH to a maximum dose of 30 mcg per day during the extension, the proportion of YORVIPATH-treated patients who maintain normal albumin-corrected serum calcium and independence from active vitamin D and therapeutic doses of calcium was 64% at Week 52 and 66% at Week 78.

Dr. Warren:
Here is an overview of what YORVIPATH dosing and titration involves. There are four steps to keep in mind—evaluate, initiate, titrate, and maintain. So, evaluate. Confirm that the 25-hydroxy vitamin D is within the normal range and albumin-corrected serum calcium is ≥7.8 mg/dL.

Then, Initiate. Start YORVIPATH at 18 mcg per day. Also, on the day of initiation, adjust the dose of active vitamin D and calcium based on albumin-corrected serum calcium and current active vitamin D and calcium intake.

Titrate. Adjust the YORVIPATH dose by three mcg increments or decrements and adjust active vitamin D and calcium based on albumin-corrected serum calcium levels in their current dose.

Finally, maintain. Once a YORVIPATH dose is at a maintenance, assess serum calcium every 4 to 6 weeks or as indicated for symptoms of hypo or hypercalcemia.

Joanna:
My formal hypoparathyroidism diagnosis came in October, 2018. For the first year after my surgery, I was on calcitriol and oral calcium, but my body couldn't tolerate them. I was experiencing many of the symptoms very typical of hypoparathyroidism. We just couldn't get it under control. It was a tough year, and I felt like I was living in a body I couldn't trust. Every time we encountered a new medical provider or I ended up in the emergency room, my condition would be dismissed as just a calcium issue. It felt like most of the doctors and nurses who treated me didn't understand hypoparathyroidism or the severity of my condition. While I was in full tetany in an ambulance on my way to the emergency room, one paramedic laughingly said, “got milk?” Not to mention emergency room doctors wanted to wait for my lab results to return. I just needed them to listen to what I was telling them about my symptoms and that my need for intervention was urgent.

Eventually, after an especially severe episode of tetany, my endocrinologist told me that we couldn't rely on the treatment plan I was on any longer. It was at that point in 2023 that one of my doctors suggested trying YORVIPATH. YORVIPATH is the first and only FDA-approved treatment for hypoparathyroidism in adults in the United States. I'm so glad that we did try YORVIPATH. Taking one shot a day has been fine for me. The best part is that my symptoms have remained pretty stable. I used to feel that my treatment was like putting little band-aids on a big wound. It was never enough. I like that YORVIPATH treats the root cause of my hypoparathyroidism. I am so thankful that my doctor and I came to this decision to start me on YORVIPATH. I'm happy, my doctor's happy, and my husband and our boys are happy with my current treatment.

YORVIPATH (palopegteriparatide) is indicated for the treatment of hypoparathyroidism in adults. YORVIPATH was not studied for acute post-surgical hypoparathyroidism. YORVIPATH’s titration scheme was only evaluated in adults who first achieved an albumin-corrected serum calcium of at least 7.8 milligrams per deciliter using calcium and active vitamin D treatment. YORVIPATH is contraindicated in patients with hypersensitivity to palopegteriparatide. Some warnings and precautions include risk of unintended changes in serum calcium levels related to the number of daily injections, hyper and hypocalcemia, risk of osteosarcoma, and orthostatic hypotension. For full safety information, please continue following along with this speaker program.