Pfizer announced that Revatio® (sildenafil citrate) has been approved by the European Commission for the treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension.1 Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease.2

"Pulmonary arterial hypertension is a rare, devastating disease, particularly when it affects children," said Dr Jonathan Jones, Medical Director of the Specialty Care Business Unit at Pfizer Limited. "The efficacy of Revatio in the treatment of paediatric patients with this disease has been demonstrated in the largest placebo-controlled clinical study conducted in this population."

The approval was based on results of a dose-ranging Phase III multi-centre, global study that evaluated the efficacy and safety of Revatio versus placebo in 234 paediatric patients with primary pulmonary hypertension or pulmonary hypertension associated with congenital heart disease. The adverse reaction profile seen in this paediatric study was generally consistent with that in adults with pulmonary arterial hypertension.2

Pulmonary arterial hypertension is a rare, progressive disease characterized by high blood pressure in the pulmonary arteries, leading to heart failure and premature death.3 In adults pulmonary arterial hypertension can occur with no known underlying cause, or it can be found in association with other disorders such as connective tissue disease or congenital heart disease.4In children, the commonest cause of pulmonary arterial hypertension is in association with congenital heart disease.

For paediatric patients, Revatio will be available as an extemporaneously prepared oral suspension compounded from Revatio 20 mg tablets and recommended diluents.2 Revatio is also available in oral and I.V. formulations for the treatment of adults with pulmonary arterial hypertension.

Revatio was first approved by the European Commission in October 2005 for the treatment of adult patients with pulmonary arterial hypertension. Revatio is approved for the treatment of patients in WHO functional class II and III, to improve exercise capacity. Efficacy has been shown in adults with primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Revatio is approved for the treatment of paediatric pulmonary arterial hypertension only in the EU with applications pending in the rest of the world.

Since its initial regulatory approval in 2005, Revatio has been approved for adult patients and is available in more than 50 countries and has amassed more than 100,000 adult patient-years of experience in the treatment of pulmonary arterial hypertension.

The approval of Revatio for the treatment of paediatric pulmonary arterial hypertension provides a licensed treatment option for children with this rare but devastating disease.

References

1. EC Approval, Adoption of COMMISSION IMPLEMENTING DECISION amending the marketing authorisation granted by Decision C(2005)4326 for "Revatio - sildenafil", an orphan medicinal product for human use

2. Revatio® Summary of Product Characteristics. Available here.

3. Tissot, C and Beghetti, M. Advances in therapies foe paediatric pulmonary hypertension Expert Review Respiratory Medicine 3(3) 265-282 (2009)

4. Galie, N et al. Guidelines for the diagnosis and treatment of pulmonary hypertension European Heart Journal 30, 2493-2537 (2009)

Source:
Pfizer