After Safety Review, EMA Concludes Doctors May Continue to Prescribe Uptravi for PAH Treatment

The European Medicines Agency (EMA) has completed its review of Uptravi (selexipag) and concluded that doctors may continue prescribing the drug to treat pulmonary arterial hypertension (PAH), according to a press release.

The 28-member European Union approved Uptravi for treating PAH in May 2016. However, after five French patients died while on Uptravi this past February, the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) launched a review of the drug.

During the process, PRAC examined the five fatal cases and studied further relevant data collected since Uptravi’s market launch. It also analyzed clinical trials and data comparing Uptravi to other existing PAH therapies. None of the data examined suggested that patients on Uptravi had higher mortality rates than those on other PAH therapies. For now, the committee recommends no further specific regulatory action. It will continue monitoring Uptravi’s safety and carefully examining emerging data as information becomes available.

Uptravi is a prostacyclin receptor agonist used for the long-term treatment of PAH. It works in a similar way to prostacyclin, a naturally occurring substance that regulates blood pressure by attaching to receptors in the muscles of blood vessel walls, causing the vessels to relax and widen.

By attaching to prostacyclin receptors, Uptravi widens the blood vessels and lowers the pressure inside them, improving symptoms of the disease.

Uptravi is authorized for use as a combination therapy with endothelin receptor antagonists (ERAs) and/or phosphodiesterase type 5 (PDE-5) inhibitors when these medicines don’t work well on their own. Uptravi is available as tablets (200; 400; 600; 800; 1,000; 1,200; 1,400 and 1,600 micrograms). Treatment should be started at a dose of 200 micrograms twice daily, every 12 hours. The dose is then increased weekly, as long as it is tolerated, to a maximum of 1,600 micrograms twice daily, which is then continued afterwards.

Safety warnings for Uptravi include reducing dosing gradually when stopping treatment, as well as carefully reading all prescribing information. Patients with severely reduced liver function should not take Uptravi.