YORVIPATH Solution for injection Ref.[51687] Active ingredients: Palopegteriparatide

Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Ascendis Pharma Bone Diseases A/S, Tuborg Boulevard 12, DK-2900 Hellerup, Denmark

Product name and form

Yorvipath 168 micrograms/0.56 mL solution for injection in pre-filled pen.

Yorvipath 294 micrograms/0.98 mL solution for injection in pre-filled pen.

Yorvipath 420 micrograms/1.4 mL solution for injection in pre-filled pen.

Pharmaceutical Form
Solution for injection (injection). Clear and colourless with a pH of 3.7-4.3.

Qualitative and quantitative composition

Yorvipath consists of PTH conjugated to a methoxypolyethylene glycol carrier (mPEG) via a Linker.

Yorvipath 168 micrograms/0.56 mL solution for injection in pre-filled pen: Each pre-filled pen contains palopegteriparatide equivalent to 168 micrograms of PTH in 0.56 mL of solvent*. The concentration based on PTH is 0.3 mg/mL. Each pre-filled pen delivers doses of 6, 9, or 12 micrograms of PTH.

Yorvipath 294 micrograms/0.98 mL solution for injection in pre-filled pen: Each pre-filled pen contains palopegteriparatide equivalent to 294 micrograms of PTH in 0.98 mL of solvent*. The concentration based on PTH is 0.3 mg/mL. Each pre-filled pen delivers doses of 15, 18, or 21 micrograms of PTH.

Yorvipath 420 micrograms/1.4 mL solution for injection in pre-filled pen: Each pre-filled pen contains palopegteriparatide equivalent to 420 micrograms of PTH in 1.4 mL of solvent*. The concentration based on PTH is 0.3 mg/mL. Each pre-filled pen delivers doses of 24, 27, or 30 micrograms of PTH.

^* The strength indicates the quantity of the PTH moiety without consideration of the mPEG-linker.

For the full list of excipients, see section 6.1.

Active Ingredient	Description
Palopegteriparatide	Palopegteriparatide is a prodrug, consisting of PTH conjugated to a methoxypolyethylene glycol carrier (mPEG) via a proprietary TransCon Linker. PTH and its main metabolite, PTH, have similar affinity to and activation of PTH1R as endogenous PTH. At physiological conditions, PTH is cleaved from palopegteriparatide in a controlled manner to provide a continuous systemic exposure of active PTH.

List of Excipients
Succinic acid Mannitol Metacresol Sodium hydroxide Hydrochloric acid (for pH adjustment) Water for injections

Pack sizes and marketing

A cartridge (type 1 glass) with a plunger (halobutyl) and a laminate rubber sheet (halobutyl/isoprene) contained in a pre-filled multidose disposable pen made of polypropylene.

Packs of two pre-filled pens and 30 disposable needles for 28 days of treatment (co-packaged in two inner cartons). Each inner carton contains one pre-filled pen and 15 needles for 14 days of treatment.

Yorvipath 168 micrograms/0.56 mL solution for injection in pre-filled pen:

Each pre-filled pen contains palopegteriparatide equivalent to 168 micrograms of PTH in 0.56 mL of solvent.
Pre-filled pen delivering doses of 6, 9, or 12 micrograms.
The strength colour on the outer carton, pen label and push button is blue.

Yorvipath 294 micrograms/0.98 mL solution for injection in pre-filled pen:

Each pre-filled pen contains palopegteriparatide equivalent to 294 micrograms of PTH in 0.98 mL of solvent.
Pre-filled pen, delivering doses of 15, 18, or 21 micrograms.
The strength colour on the outer carton, pen label and push button is orange.

Yorvipath 420 micrograms/1.4 mL solution for injection in pre-filled pen:

Each pre-filled pen contains palopegteriparatide equivalent to 420 micrograms of PTH in 1.4 mL of solvent.
Pre-filled pen, delivering doses of 24, 27, or 30 micrograms.
The strength colour on the outer carton, pen label and push button is burgundy.

Marketing authorization holder

Ascendis Pharma Bone Diseases A/S, Tuborg Boulevard 12, DK-2900 Hellerup, Denmark

Marketing authorization dates and numbers

EU/1/23/1766/001
EU/1/23/1766/002
EU/1/23/1766/003

Drugs

Drug	Countries
YORVIPATH	Austria, Estonia, Croatia, Ireland, Italy, Lithuania, United States

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