Swedish pharmaceutical company Newbury Pharmaceuticals AB (STO:NEWBRY) announced on Friday that it has received marketing authorisation for Macitentan Newbury in Denmark.

This is the first approval in a Scandinavian registration process. Approvals in Sweden and Norway are expected following national reviews.

Macitentan is used for the long-term treatment of pulmonary arterial hypertension (PAH), a condition causing high blood pressure in the lungs and leading to breathlessness and fatigue. It is indicated for adults, adolescents and children weighing at least 40 kg with moderate or marked physical limitations due to PAH. The drug can be used alone or in combination with other PAH treatments.

Macitentan Newbury is a generic version of Opsumit. The Scandinavian market for the drug is valued at approximately EUR15m annually, according to DLMI Nordic Pharma Insights.

Newbury Pharmaceuticals plans to launch the product in respective markets once regulatory exclusivities and patents allow.