Pharming receives European Commission approval for treatment of acute hereditary angioedema attacks in children with RUCONEST®
Pharming Group N.V. announces that it has received formal European Commission approval to treat acute hereditary angioedema (HAE) attacks in children with RUCONEST®. Following the positive opinion and recommendation from the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on the extension of the indication for RUCONEST® received on 26 March 2020.
- Pharming has received a formal European Commission (EC) decision on the approval of a new RUCONEST® license extension in Europe
- European Commission decision was received six weeks earlier than expected
- The extension of the indication means that RUCONEST® is now approved for the treatment of acute angioedema attacks in adults, adolescents, and children (aged two years and above) with hereditary angioedema (HAE) due to C1 esterase inhibitor deficiency in Europe
''We are pleased to receive approval from the European Commission and to be able to offer RUCONEST® as a treatment for acute HAE attacks in all patients aged two years and above. ''- Sijmen de Vries - CEO