Severe asthma mAb approved in pre-filled single use pen for self-administration

22nd January 2023

Tezepelumab is a treatment for patients with severe asthma and has been approved in the EU as a pre-filled pen for self-administration

In a press release from the manufacturer, AstraZeneca, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has now approved a pre-filled pen containing tezepelumab, for self-administration to patients aged 12 years and older with severe asthma. The release adds that the CHMP opinion can actually be implemented without the need for a European Committee decision due to the nature of the type II label variation.

Tezepelumab is a first-in-class monoclonal antibody that specifically binds to thymic stromal lymphopoietin thereby stopping its interaction with the heterodimeric receptor. Thymic stromal lymphopoietin is an epithelial-derived cytokine with an important role in both the initiation and persistence of airway inflammation in asthma. When used as an add-on treatment for patients with severe, uncontrolled asthma, tezepelumab has been shown to be both safe and effective. Data for the drug in patients with severe asthma has shown that it leads to fewer disease exacerbations, improved lung function, asthma control and health-related quality of life compared with placebo.

Tezepelumab (brand name Tezspire) will be available as a fixed-dose 210mg subcutaneous injection via a pre-filled, single use auto-injector but also as single-use syringe with both forms designed to be given every four weeks. The pre-filled pen enables both patients and carers to self-administer the treatment at home.

Tezepelumab pre-filled pen efficacy

Data on the use of the pre-filled pen comes from a study which showed that in 315 adults, the pre-filled syringe provided similar pharmacokinetic parameters when compared to a single subcutaneous dose. In addition, a second study showed that use of the pre-filled syringe and an auto-injector gave rise to similar and clinically meaningful improvements in the asthma control questionnaire-6 score after 24 weeks.

In the press release, Professor Ian Pavord, Professor of Respiratory Medicine at the University of Oxford and Honorary Consultant Physician at the Oxford University Hospitals, said: ‘Severe asthma continues to have a debilitating impact for people living with the disease. I believe the approval of the Tezspire pre-filled pen will be welcome news for physicians and patients in Europe as it offers increased choice and greater flexibility when administering this important medicine.’

AstraZeneca has also submitted data to the US Food and Drug Administration for approval of the pre-filled pen.