GlaxoSmithKline Plc (LON/NYSE: GSK) today announced that the European Medicines Agency’s (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.
If approved, the two new Nucala options will offer healthcare professionals the choice of prescribing at-home administration for appropriate patients. The original lyophilised powder version remains available for administration in clinic by a healthcare professional.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission.
Data supporting the recommendation
The CHMP opinion is supported by positive experience data from two open-label, single-arm, phase IIIa studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in clinic and at home by patients with severe eosinophilic asthma, or their caregivers. Both studies showed patients were able to successfully self-administer treatment with both the pre-filled pen and pre-filled safety syringe after appropriate training (89-95% and 100% respectively). In addition, the majority of patients preferred at-home administration options compared to in-clinic administration.
A further open-label, parallel-group, single-dose pharmacokinetic and pharmacodynamic study (NCT03014674), confirmed that the profile of Nucala administered via the pre-filled safety syringe or pre-filled pen was comparable to the originally approved lyophilised formulation.