Yorvipath Approved for Hypoparathyroidism

On Aug. 9, 2024, the U.S. Food and Drug Administration (FDA) approved Ascendis Pharma’s Yorvipath^® (palopegteriparatide) for the treatment of hypoparathyroidism in adults. It is a parathyroid hormone analog [PTH(1-34)] that is administered as a once-daily subcutaneous (SC) injection. Dosing varies based on a patient’s serum calcium level. The maximum daily dose is 30mcg. Yorvipath will be supplied as pre-filled syringes in three different strengths. The 168mcg/0.56mL pen is for patients requiring doses of 6mcg, 9mcg or 12mcg. The 294mcg/0.98mL pen is for patients requiring doses of 15mcg, 18mcg or 21mcg. The 420mcg/1.4mL pen is for patients requiring doses of 24mcg, 27mcg or 30mcg. Yorvipath is expected to be available in the fourth quarter of 2024. Pricing information is not yet available. Full prescribing information can be found here.

At a Glance

• Brand Drug: Yorvipath^® (palopegteriparatide)
• Manufacturer: Ascendis Pharma
• Date Approved: Aug. 9, 2024
• Indication: for the treatment of hypoparathyroidism in adults
• Dosage Forms Available: single-patient-use prefilled syringes for SC injection: 168mcg/0.56mL, 294mcg/0.98mL and 420mcg/1.4mL
• Launch Date: Q4:2024
• Estimated Annual Cost: Not yet available
• Hypoparathyroidism is an endocrine disorder that affects between 70,000 and 90,000 adults in the United States. Parathyroid hormone (PTH) is needed to regulate and balance two minerals in the body, calcium and phosphorus. Patients with hypoparathyroidism have low levels of PTH; therefore, the body produces low levels of calcium and high levels of phosphorus in the blood. Hypoparathyroidism may cause a variety of symptoms including tingling or burning in the fingertips, toes, and lips. It can cause muscle aches and spasms as well as weakness or fatigue. Some long-term complications may include seizures, kidney dysfunction, abnormal heart rhythms and heart failure.
• Patients are typically treated with oral calcium supplements and high doses of vitamin D. Some patients are also treated with magnesium and thiazide diuretics.
• Natpara^® (parathyroid hormone) is currently approved to treat hypoparathyroidism; however, Takeda plans to discontinue this medication by the end of 2024. Natpara’s labeling contains a boxed warning concerning its potential risk for causing osteosarcoma (a malignant bone tumor). It was also approved with a risk evaluation and mitigation strategy (REMS).
• Approval of Yorvipath was based on a Phase III study that showed that at Week 26, 69% of treated patients reached the primary efficacy endpoint, which included albumin-corrected serum calcium in the normal range and independence from conventional therapy, compared to 4.9% in the placebo group.
• The most common adverse events experienced by patients in the trial were injection site reactions, vasodilatory signs and symptoms, headache, diarrhea, back pain, hypercalcemia, and oropharyngeal pain.