YORVIPATH Revolutionizes Hypoparathyroidism Treatment

Ascendis Pharma A/S (Nasdaq: ASND) today announced that YORVIPATH® (palopegteriparatide), developed as TransCon PTH, is now available by prescription in the U.S. YORVIPATH is the first and only FDA-approved treatment for hypoparathyroidism in adults, designed as a once-daily prodrug delivering continuous parathyroid hormone (PTH) exposure over 24 hours.

A Milestone for Patients and Caregivers

Patty Keating, Executive Director of the HypoPARAthyroidism Association, expressed enthusiasm about the availability:

“This marks a transformative step for patients, providing a new approach to addressing this hormone deficiency.”

Jan Mikkelsen, Ascendis Pharma’s President and CEO, emphasized the company’s commitment:

“We aim to meet the urgent needs of the hypoparathyroidism community with affordable, broad access to YORVIPATH.”

Patient Support Through Ascendis Signature Access Program®

To enhance access, Ascendis established the U.S. YORVIPATH team under the Ascendis Signature Access Program®. The program offers specialized nurse support, education, assistance with prior authorization, injection training, and co-pay support for eligible patients.

Important Safety Information

• Indication: YORVIPATH is approved for adults with hypoparathyroidism.
• Contraindications: Severe hypersensitivity to palopegteriparatide or excipients.
• Warnings: Includes risks of hypercalcemia, hypocalcemia, orthostatic hypotension, osteosarcoma potential, and digoxin toxicity. Patients must adhere to a single daily injection to avoid unintended calcium fluctuations.
• Adverse Reactions: Common side effects include injection site reactions (39%), vasodilatory symptoms (28%), headache (21%), and hypercalcemia (8%).

Guidance for Specific Populations

Pregnant and lactating women should be monitored for calcium-related issues. Providers are encouraged to report any exposure during pregnancy by calling 1-844-442-7236.

YORVIPATH offers a significant advancement for patients and healthcare providers managing hypoparathyroidism, addressing an unmet medical need with a new treatment paradigm.