Pfizer receives EU approval for paediatric Revatio indication

Pfizer has been granted approval to market its pulmonary arterial hypertension treatment Revatio for use among paediatric patients in the EU.

The drug, which has been approved for adult use since 2005, has been given the green light by the European Commission to be utilised among patients aged between one and 17 years old for the first time.

Approval was granted based on positive data from a phase III clinical trial, which demonstrated its safety and efficacy in improving exercise capacity among those in this age group compared to placebo.

Dr Cara Cassino, vice-president of Pfizer's medicines development group, said: "With the approval of Revatio, these young patients now have an important treatment option that may help manage their condition."

To date, Revatio has been approved and launched in more than 50 countries worldwide.

Earlier this year, the company was granted European approval for the launch of Xiapex, a new therapy option for Dupuytren's contracture.