Posted by Michael Wonder on 14 Dec 2017
New formulation of Oncaspar (pegaspargase) receives marketing authorisation in Europe for patients with acute lymphoblastic leukaemia
13 December 2017 - Freeze-dried, or lyophilised, formulation aims to improve supply management by providing the same dosing regimen as liquid Oncaspar, but with a three-times longer shelf life of up to 24 months.
Shire today announced that the European Commission granted marketing authorisation for lyophilised Oncaspar (pegaspargase), as a component of anti-neoplastic combination therapy in acute lymphoblastic leukaemia in paediatric patients from birth to 18 years, and in adult patients
The approval – which authorises Shire to market lyophilised Oncaspar in the 28 member states of the European Union as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the CHMP of the EMA on 12 October.
