Pfizer has been boosted by the news that regulators in Europe have expanded approval of the US giant's pulmonary arterial hypertension drug Revatio to cover children.
Specifically, the European Commission has given the thumbs-up to Revatio (sildenafil) for the treatment of paediatric patients aged 1 to 17 years old with PAH. The approval is based on results of a Phase III study involving 234 paediatric patients with PAH associated with congenital heart disease.
The expanded approval for Revatio, which has the same active ingredient as Pfizer's erectile dysfunction drug Viagra, was expected after the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the drug in March. It was authorised in Europe for adults with PAH in 2005, and the old continent is the only area where the paediatric indication has been approved.
Cara Cassino, vice president of Pfizer Medicines Development Group, noted that PAH "is a rare, devastating disease that can affect children" and with the approval of Revatio, "these young patients now have an important treatment option that may help manage their condition". The approval "is another example of our ongoing commitment to rare diseases", Dr Cassino added.