GSK's Nucala (mepolizumab) Receives European Commission Approval for Self-Administration in Severe Eosinophilic Asthma
Shots:
- The Nucala has received EMA’s marketing authorization for its new methods of administration i.e- a pre-filled pen and a pre-filled safety syringe with their anticipated launch in Europe in Aug’2019
- The MAA is based on two P-IIIa studies (NCT03099096 & NCT03021304) which demonstrated that patients were able to administer Nucala with the pre-filled pen and pre-filled safety syringe after training (98% & 100%) respectively
- Nucala (mepolizumab) is a once-monthly anti-IL5 biologic and is an approved therapy in the US- Europe- and other 20+ countries as an add-on maintenance treatment for SEA- currently being evaluated for the hypereosinophilic syndrome- nasal polyposis and COPD
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