Trial Profile
An Open-label, Single Arm, Repeat Dose, Multi-centre Study to Evaluate the Use of a Safety Syringe for the Subcutaneous Administration of Mepolizumab in Subjects With Severe Eosinophilic Asthma (Study 205667)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Sep 2023
Price :
$35
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At a glance
- Drugs Mepolizumab (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Sponsors GlaxoSmithKline; GSK
- 11 Jun 2019 Romania was a planned location
- 06 Jun 2019 According to a GlaxoSmithKline media release, based on the data of NCT03099096 & NCT03021304, the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe for patients with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis (EGPA).
- 04 Jun 2019 According to a GlaxoSmithKline media release, based on the data of NCT03099096 & NCT03021304, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending two new methods for administering Nucala (mepolizumab) to patients with severe eosinophilic asthma: a pre-filled pen and a pre-filled safety syringe, to be taken once every four weeks.