Resnais schreef op 2 april 2020 12:25:
HAE in children
Pharming is conducting an open-label Phase II clinical study evaluating Ruconest® for the treatment of acute attacks of
angioedema in paediatric patients with HAE. The Ruconest® paediatric study has been agreed with the European Medicine
Agency’s (EMA) Paediatric Committee and is expected to enrol approximately 20 patients, from 2 up to and including 13
years of age. This study, if successful, could broaden the label for Ruconest® in Europe and also has the additional benefit
of extending the regulatory exclusivity period, both of which are commercially important. Ruconest® has regulatory
exclusivity in Europe until late 2025 and paediatric exclusivity will add another six months, extending the exclusivity period to
2026.
( Pharming_AR_2013_3 PDF )