The European Medicines Agency (EMA) is reviewing the safety of Uptravi (selexipag) after the deaths of five patients with pulmonary arterial hypertension (PAH) who took the medicine in France.
The European Union approved Uptravi for the treatment of PAH in May 2016.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will re-examine all data on Uptravi, according to a press release. In the meantime, after a preliminary review, EMA is advising patients to continue using Uptravi — but in strict compliance with prescribing instructions.
The permanent review is based on what is known as a safety signal – information on a new or undocumented adverse event potentially caused by a therapy that needs further investigation. Once the review is completed, PRAC will publish its final conclusions.
As EMA reviews the data, doctors should pay close attention to Uptravi prescription instructions, particularly the precautions. And patients taking the drug should observe their doctors’ instructions.
Uptravi is a long-term treatment for PAH. EMA authorized it in combination with other medicines — endothelin receptor antagonists (ERAs) and phosphodiesterase type 5 (PDE-5) inhibitors. A combination treatment is recommended when therapies do not work well enough on their own, or when patients are advised against taking one of them.
Europe’s marketing authorization for Uptravi was based on results of the Phase 3 GRIPHON clinical trial (NCT01106014), which evaluated the safety of Uptravi in PAH patients. The 1,156 patients enrolled in this trial received treatment for up to 4.2 years.
Researchers concluded that Uptravi reduced by 40 percent the risk of patients developing PAH-related complications or dying, compared with a placebo. It found consistent benefits across all subgroups analyzed.
The study established the drug’s effectiveness, safety and tolerability in PAH patients that the World Health Organization functional classification system lists in Classes 2 and 3. Class 2 patients have no symptoms at rest but experience discomfort performing normal daily activities. Class 3 patients may not have symptoms at rest but their daily activities are greatly limited by shortness of breath, fatigue or near fainting.
Patients with questions about treatment with Uptravi should consult their doctor or pharmacist.