A new form of administration of benralizumab, AstraZeneca’s biological drug, has been registered in the Russian Federation. It is an autoinjector pen that patients can use at home without medical assistance. This was reported by the press service of the company.
The approval of this administration form of benralizumab was based on the results of phase 3 GRECO and phase 1 AMES clinical trials. The data on the safety and tolerability of the drug in these studies confirmed the results obtained earlier in the reference studies. The autoinjector form of benralizumab had been earlier approved in the EU and in the US.
Benralizumab was registered in Russia in 2019 as an add-on maintenance therapy for the treatment of asthma with an eosinophilic phenotype. But until now, it has been released only in the form of a pre-filled syringe for subcutaneous administration by medical workers.
“Benralizumab is intended for the treatment of patients with severe eosinophilic asthma; it blocks the human interleukin-5 (IL-5) receptor. The new form of administration will allow patients to use the drug at home without medical assistance. We hope that the independent use of a syringe pen will increase the patients’ adherence to the prescribed treatment and significantly improve their quality of life, since there will be no need to visit a medical institution every time an injection is needed. This is a great opportunity for patients not only to control the disease, but also to maintain their usual lifestyle,” commented Anna Brashchenkova, Medical Director of Biopharma, AstraZeneca Russia and Eurasia.
“Self-administration of benralizumab with an autoinjector pen has a number of advantages. First, patients are no longer tied to a specific medical institution only for another injection of the drug as part of the prescribed therapy. Secondly, the use of a pen autoinjector at home may be important for patients with limited mobility who are unable to visit medical institutions regularly,” said Sergey Avdeev, Doctor of Medical Sciences, Professor, Corresponding Member of the Russian Academy of Sciences, Chief Consultant Pulmonologist of the Ministry of Health of the Russian Federation, Head of the Pulmonology Department of the I. M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation.