Summary report on authorisation – Yorvipath®

Authorisation in Switzerland: 9 December 2025

Solution for injection in pre-filled pen for the treatment of hypoparathyroidism in adults

Yorvipath contains the active substance palopegteriparatide.

Yorvipath is a hormone replacement medicine for treating adults with chronic underfunction of the parathyroid glands (hypoparathyroidism).

Patients with this condition have a deficiency of parathyroid hormone, which in turn leads to calcium deficiency since parathyroid hormone plays an important role in regulating calcium levels. As a result, sufferers experience problems with their bones, muscles, heart, kidneys and other parts of the body.

Since this is a rare and life-threatening disease, the medicine has been authorised as an orphan drug. "Orphan drug" is a designation given to medicinal products for rare diseases.

Yorvipath was authorised under Article 13 of the Therapeutic Products Act (TPA). This means that the medicinal product is already authorised in another country with comparable medicinal product control.

In this case, Swissmedic takes into consideration the results of checks carried out by foreign regulatory agencies, provided certain requirements are fulfilled.

The consideration of the results of foreign authorisation procedures is intended to help ensure that medicines that are already authorised abroad can be made available to patients in Switzerland as quickly as possible.

The authorisation of Yorvipath in Switzerland is based on the assessment and approval decision of the European Medicines Agency (EMA, Procedure No. EMEA/H/C/005934/0000). Swissmedic has only conducted a limited scientific review.

Accordingly, in the SwissPAR (Swiss Public Assessment Report) and the resulting Summary report on authorisation, Swissmedic refers to the Assessment Report (EMA/439682/2023) and the short report issued by the reference authority: https://www.ema.europa.eu

The active substance of Yorvipath, palopegteriparatide, is converted in the body to teriparatide. Teriparatide replaces the missing parathyroid hormone in the body.

Yorvipath is a prescription-only medicine and is injected under the skin of the abdomen or thigh as a solution for injection in pre-filled pen.

Yorvipath is available as a solution for injection in pre-filled pens in doses of 168 µg/0.56 mL, 294 µg/0.98 mL and 420 µg/1.4 mL.

The usual starting dose is 18 µg per day. The starting dose can be adjusted gradually to daily doses between 6 and 30 µg.

The efficacy of Yorvipath was investigated in a study with 84 patients with hypoparathyroidism. Over a period of 26 weeks, the study showed that Yorvipath, compared to a dummy drug (placebo), stabilised blood calcium levels within the normal range in the majority of patients.

Yorvipath must not be used in those who are hypersensitive to the active substance or any of the excipients.

The most commonly observed undesirable effects of Yorvipath were injection site reactions, dizziness, headache and paraesthesia (unusual sensations such as tingling).

All precautions, risks, and other possible undesirable effects are listed in the Information for patients (package leaflet) and the Information for healthcare professionals.

Yorvipath can effectively regulate calcium levels in the body in patients with hypoparathyroidism. Taking all the risks and precautions into account, and based on the available data, the benefits of Yorvipath outweigh the risks. Swissmedic has therefore authorised the medicinal product Yorvipath, containing the active substance palopegteriparatide, for use in Switzerland.

Information for healthcare professionals:

Yorvipath®

Information for patients (package leaflet):

Yorvipath

Healthcare professionals can answer any further questions.

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^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}