Pfizer’s Revatio extends Europe PAH licence
pharmafile | May 9, 2011 | News story | Sales and Marketing | PAH, Pfizer, pulmonary arterial hypertension, revatio
Pfizer’s Revatio has been approved by European regulators for the treatment of pulmonary arterial hypertension (PAH) in children.
The European Commission has given the green light to phosphodiesterase-5 inhibitor Revatio (sildenafil) for pediatric patients – the first regulator to do so for children, although applications in other territories are pending.
Patients aged from one to 17 will take the drug as a prepared oral suspension compounded from Revatio 20 mg tablets and recommended diluents.
“With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition,” said Cara Cassino, vice president, Pfizer Medicines Development Group.
A variety of treatments, such as Actelion’s market leader Tracleer, are available for adults in the $2.5 billion global PAH market and Revatio was originally approved by the EC in October 2005.
The latest EC decision was based on a phase III study looking at Revatio versus placebo in more than 200 children with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease.
Primary endpoint was improvement from baseline in exercise capacity as assessed by change in peak volume of oxygen consumption (peak VO2) after 16 weeks.
Estimated change in peak VO2 in patients with the rare disease receiving any dose of Revatio was 7.71% and improvements in pulmonary vascular resistance index (PVRI) and mean pulmonary arterial pressure (mPAP) were also observed.
Of 120 patients who were WHO functional class II, III or IV at baseline, 32 improved by one class, and one child by two classes.
At the same time, four of the 35 patients in the placebo group improved by one class.
Revatio’s success in children who could not perform the exercise test was assessed using secondary endpoints such as hemodynamics and change in WHO functional class.
Pfizer suffered a blow to its drug development programme in December with the voluntary withdrawal of its PAH brand Thelin due to the threat of life-threatening liver damage.
But last year it also signed an agreement to acquire terguride, a PAH drug in phase II testing, from Swiss company Ergonex GmbH.
The orally-active antagonist of serotonin 5-HT2B and 5-HT2A receptors has a different mechanism of action to both Thelin and Revatio.
Adam Hill
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