Pfizer has received FDA approval for Revatio (sildenafil) injection, an intravenous formulation of Revatio. Revatio is the FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations.
Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension, to improve exercise ability and delay clinical worsening. The delay in clinical worsening was demonstrated when Revatio was added to background epoprostenol therapy.
The company said that Revatio injection is for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio tablets, but who are temporarily unable to take oral medication.
Cara Cassino, vice president of pulmonary vascular disease of clinical development and medical affairs at Pfizer, said: “The approval of Revatio 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 unit’s dedication to advancing treatments for serious and life-threatening conditions such as pulmonary vascular disease.”