Benralizumab

Benralizumab is a monoclonal antibody which directly contacts α-subunit of a receptor of interleukin 5 (IL-5) on a surface of eosinophils and attracts NK cages (natural killers) to cause fast and almost complete depletion of eosinophils by means of apoptosis (the programmed cellular death).

Benralizumab was developed by Astrazeneka company and Kiova Hakko Kirin Co is redeemed from Biova Ink. company, subsidiary company ". Ltd." (Japan).

2019

Positive influence of a benralizumab on patients with a gipereozinofilny syndrome

Application of a benralizumab can lead to almost complete depletion of eosinophils and improvement of clinical results at patients with a gipereozinofilny syndrome (HEPS). It was shown in phase research II which data are published in the New England Journal of Medicine magazine, Zdrav.Expert in Astrazeneka company reported on April 29, 2019.

The hydroelectric power station is group of the rare and potentially lethal diseases which are characterized by the high content of eosinophils in the blood and body tissues which are followed by the progressing and life-threatening damage of internals. At the beginning of the phase research II the maintenance of eosinophils in blood of patients was significantly increased — from 1000 to 21 580 cages in 1 mkl.

During a blind phase of a research for participation in which there were randomizirovano 20 patients, as primary endpoint for efficiency evaluation served the share of patients (as a percentage) at whom by 12th week of a research the absolute number of eosinophils in peripheral blood decreased by 50% and more. This endpoint was reached at 90% of the patients receiving benralizumab in comparison with 30% of the patients receiving placebo (statistically significant distinction).

During an open investigation phase at 74% of patients decrease in quantity of eosinophils remained till 48th week of a research, and during this period clinical improvement of symptoms of a disease was observed. At 64% of patients it was succeeded to reduce use of medicines for basic therapy of the HEPS. Almost complete depletion of eosinophils was observed also in fabrics (a mucous membrane of digestive tract and skin) which samples were taken for carrying out a biopsy. During the period of therapy, the lasting 48 weeks, three most often registered undesirable phenomena connected using a benralizumab included a headache, increase in maintenance of a lactatedehydrogenase (LDG) and a fever. The observed increase in LDG arose after application of the first dose of a benralizumab and was allowed within 48 hours.

We are inspired by such results of a research of a benralizumab at a gipereozinofilny syndrome. Data retrieveds can be very important, considering a limited number of methods of treatment of this disabling disease — Mene Pangalos, the executive vice president and the president of the direction of research and development of biological medicines said.

In February, 2019 the Management on sanitary inspection behind quality of foodstuff and medicines (FDA) of the USA gave to a benralizumab the status of orphan medicine for treatment of the HEPS.

The research was conducted by Astrazeneka company in cooperation with the National Institute of an allergy and infectious diseases (NIAD) of the USA which is a part of National Institutes of health care of the USA.

Benralizumab is approved for treatment of heavy eozinofilny bronchial asthma

For April, 2019 benralizumab is the first biological medicine of Astrazeneka company for treatment of respiratory diseases approved to application as means of the additional supporting therapy for treatment of heavy eozinofilny bronchial asthma in the USA, the EU, Japan and other countries. At the same time consideration of further statements for medicine registration continues. In the Russian Federation the registration file on benralizumab is under consideration in the Ministry of Health of the Russian Federation.

In the countries where benralizumab it is registered, it is available in the form of solution to hypodermic introduction with the fixed dose in previously filled syringe. Introduction of the three first doses of medicine is performed 1 time in 4 weeks, the subsequent doses enter 1 time each 8 weeks. Besides, application of a benralizumab is studied also at patients with a heavy nasal polipoz.