The European Commission (EC) has approved Pfizer’s Revatio (sildenafil) solution for injection in patients who are currently prescribed oral Revatio and who are temporarily unable to take oral medicine, but are otherwise clinically and haemodynamically stable.
The company claims that Revatio is the only phosphodiesterase 5 (PDE5) inhibitor with both oral and IV formulations approved in the EU for the treatment of pulmonary arterial hypertension (PAH).
The company said that Revatio solution for injection is for adult patients with PAH who are stable on Revatio tablets but are temporarily unable to take oral medication, and for whom the physician considers continuity of treatment to be in the patients’ best interest.
Cara Cassino, vice president of pulmonary vascular disease, clinical development and medical affairs at Pfizer, said: “The approval of Revatio solution for injection is a clear demonstration of Pfizer’s commitment to developing treatments addressing the unmet needs of patients with pulmonary arterial hypertension.
“This important milestone highlights the Specialty Care Business Units dedication to advance treatments for serious and life-threatening conditions such as pulmonary vascular disease.”