Alteogen said on the 19th that its partner Merck (MSD) has obtained marketing authorization from the European Commission (EC) for the subcutaneous (SC) formulation anticancer drug "Keytruda SC."
Keytruda SC uses Alteogen's ALT-B4 platform technology, which converts intravenous formulations into subcutaneous formulations.
The European Commission authorized the use of Keytruda SC across all 33 adult indications for which the existing intravenous Keytruda has been approved.
With this approval, the path to commercialization has opened in Europe following the United States.
The subcutaneous formulation dramatically reduces administration time compared with the intravenous formulation, improving patient convenience. The company said that, given the subcutaneous route requires only about 1 minute for dosing once every 3 weeks and about 2 minutes once every 6 weeks, it can be administered in a variety of healthcare settings, including private clinics and community clinics, significantly improving patient access.
The approval came about two months after MSD received a positive opinion for marketing authorization of subcutaneous Keytruda from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) in September.
Park Soon-jae, CEO of Alteogen, said, "Keytruda SC, which uses ALT-B4, has been approved in Europe following the United States and will be widely used in major pharmaceutical markets," adding, "In addition to cooperation with our existing technology licensing partners, it will serve as a reliable and important reference for new partners, positively influencing the expansion of future partnerships."