New FASENRA® data from the MELTEMI extended trial confirms the long-term safety and effectiveness of severe eosinophilic asthma for up to five years

The data confirm that FASENRA is safe, consistent with the previous phase III trial

During the open-label period, at least 75% of patients with elevated blood eosinophil levels who receive FASENRA each year have zero exacerbations

A new comprehensive analysis including data from the MELTEMI Phase III open label extension trial showed that FASENRA^® (Benralizumab) has been tolerated for up to five years, and its long-term safety is consistent with previous phase III trials for adult patients with adult asthma.

The results were presented today at the American Thoracic Society (ATS) 2021 International Conference.

During the extended trials of BORA and MELTEMI, the incidence of adverse events (AE) and serious adverse events (SAE) was not comparable to the placebo observed in the Phase III pivotal trial. In all treatment groups, the incidence of severe infection, hypersensitivity, immunogenicity and malignant tumors was low, and there were no deaths during the treatment. During the open label period, the most commonly reported AEs in patients receiving FASENRA every eight weeks were nasopharyngitis, asthma, headache, and bronchitis. These data confirm FASENRA’s Complete security profile.

Among the secondary endpoints, FASENRA maintained the reduction in acute asthma attack rates observed in the phase III clinical trials of SIROCCO, CALIMA, ZONDA, and BORA. During the five-year treatment period, the annual acute asthma attack rate (AAER) remained low. Level.

In patients who received FASENRA’s high-dose inhaled corticosteroids (ICS) every eight weeks with blood eosinophil levels greater than or equal to 300 cells, AAER decreased from 3.1 exacerbations/year before treatment to 0.5/year before. In the fourth year of the public trial, it was further reduced to 0.2. In the same treatment group, 59% of patients experienced zero exacerbation within four years of the open label period (BORA and MELTEMI), and at least 75% of patients experienced zero exacerbation each year. In the last year of the trial, 87% of the patients’ condition deteriorated to zero.

Arnaud Bourdin, director of the Department of Pulmonology at the Arnold Villeneuve Hospital in Montpellier, France, Professor of Respiratory Medicine, and the principal investigator of MELTEMI, said: “Clinicians who treat severe eosinophilic asthma want to make sure that the treatments they prescribe will continue to help Patients control the disease. Based on the new MELTEMI data, doctors and their patients should be confident, because FASENRA provides a treatment plan that can do this, which is to reduce the severity of the disease with a known safety profile, thereby enabling doctors and their patients Full of confidence.”

Mark White, FASENRA’s Global Franchise Leader, said: “The new data from MELTEMI is exciting because they confirm the efficacy and safety profile seen in FASENRA’s previously reported Phase III clinical trials. These results should enable doctors and patients to take a step forward. Believe in their positive results “The experience of using FASENRA can be maintained for a long time. ”

FASENRA is currently approved as an additional maintenance treatment for severe eosinophilic asthma in the United States, the European Union, Japan and other countries/regions, and it has also been approved for self-management in the United States and the European Union. The US Food and Drug Administration (FDA) awarded FASENRA the title of orphan drug for the treatment of eosinophilic granuloma with polyangiitis (EGPA) (November 2018), Eosinophilic syndrome (HES) (February 2019) ) And Eosinophilic Esophagitis (EoE) (August 2019).

Important safety information

Contraindications

Known allergy to benralizumab or excipients.

Warnings and precautions

Allergic reaction

Hypersensitivity reactions (such as allergic reactions, angioedema, urticaria, skin rashes) occur after taking FASENRA. These reactions usually occur within a few hours after administration, but in some cases the onset is delayed (ie, several days). If hypersensitivity occurs, stop using it.

Acute asthma symptoms or worsening of the disease

FASENRA should not be used to treat acute asthma symptoms, acute attacks or acute bronchospasm.

Reduce corticosteroid dose

When starting treatment with FASENRA, do not suddenly interrupt systemic or inhaled corticosteroid therapy. If appropriate, the dose of corticosteroids should be gradually reduced and carried out under the direct supervision of a doctor. The reduction in corticosteroid dose may be related to systemic withdrawal symptoms and/or exposure conditions previously suppressed by systemic corticosteroid therapy.

Parasite (worm) infection

It is not known whether FASENRA affects the patient’s response to worm infections. Before starting treatment with FASENRA, patients with pre-existing helminth infections should be treated. If the patient is infected while receiving FASENRA and does not respond to antihelminthics, please discontinue FASENRA until the infection subsides.

Indications

FASENRA is indicated for additional maintenance treatment for patients 12 years and older with severe asthma and eosinophilic phenotype.

• FASENRA is not suitable for the treatment of other eosinophilic diseases

• FASENRA is not suitable for the relief of acute bronchospasm or asthma

Adverse reactions

The most common adverse reactions (incidence ≥5%) include headache and pharyngitis. The incidence of injection site reactions (eg, pain, erythema, itching, papules) was 2.2% in patients treated with FASENRA, compared to 1.9% in patients treated with placebo.

Use in specific populations

The Pregnancy Exposure Registry can monitor the pregnancy outcome of women exposed to FASENRA during pregnancy.To register, please call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.

Data on pregnancy exposure in clinical trials are not sufficient to inform the risks associated with drugs. In the third trimester, monoclonal antibodies such as benralizumab are transported in the placenta; therefore, the potential impact on the fetus may be greater in the third trimester.

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Severe asthma

Asthma is a heterogeneous disease, with an estimated 339 million people infected worldwide. Approximately 10% of asthma patients suffer from severe asthma. Despite the use of inhaled asthma control drugs, currently available biological therapies and oral corticosteroids (OCS), many patients with severe asthma are still unable to control it. Due to the complexity of severe asthma, many patients have unclear or multiple inflammatory drivers, and may not meet or respond well to existing biologic drugs.

Severe, uncontrollable asthma makes patients weaker, their illnesses are frequent, their lung function is severely restricted, and their health-related quality of life decreases. Patients with severe asthma have an increased risk of death, and the risk of hospitalization associated with asthma is twice that. There is also a great socioeconomic burden, and these patients account for more than 50% of asthma-related expenses.

Merti

MELTEMI is a multi-center, open-label, safety-expansion phase III clinical trial designed to evaluate the use of ICS and long-acting beta 2 agonist therapy in patients with severe, uncontrolled asthma (with or without chronic OCS and/ Or other asthma) the safety and tolerability controller of subcutaneous injection of FASENRA. Participants completed one of the three placebo-controlled preliminary trials (SIROCCO, CALIMA, ZONDA), then participated in the double-blind BORA safety extension trial, and further transitioned to the MELTEMI open label extension trial.

The results of the comprehensive analysis included patients who received FASENRA within five years from the beginning of the treatment period of the previous study. A total of 446 patients were included in the analysis. Among them, 384 (86.1%) completed the treatment period, and 16% had a treatment period of more than or equal to five years. The average duration of treatment in each group was equal to or greater than three years. As is commonly observed in long-term trials, the number of patients who complete the later phases of the study is less than the patients who complete the previous trials due to the time the subject is tracked.

The primary endpoint of MELTEMI is the safety and tolerability of FASENRA, which is measured by the incidence of AE and SAE during treatment. Secondary endpoints include the primary and secondary endpoints of the Phase III pre-study: annual asthma attacks, hospitalization and/or emergency department visits, absolute eosinophil count during treatment; and immunogenicity.

Fasenra

FASENRA (benacizumab) is a monoclonal antibody that directly binds to IL-5 receptor α on eosinophils and attracts natural killer cells, thereby inducing apoptosis (programmed cell death) in most Causes rapid and almost complete consumption of blood and tissue eosinophils in patients.

FASENRA is currently approved as an additional maintenance treatment for severe eosinophilic asthma in the United States, the European Union, Japan and other countries/regions, and has been approved for self-management in the United States, the European Union and other countries/regions.

FASENRA is developing other eosinophilic diseases and chronic obstructive pulmonary diseases. The US Food and Drug Administration (FDA) awarded FASENRA the orphan drug designation for EGPA (November 2018), HES (February 2019) and EoE (August 2019).

FASENRA was developed by AstraZeneca and licensed by BioWa, Inc., a wholly-owned subsidiary of Japan Kyowa Kirin Co., Ltd.

AstraZeneca’s Respiratory and Immunology

Respiratory and immunology are part of biopharmaceuticals, one of AstraZeneca’s three therapeutic areas, and the main driving force for the company’s growth.

AstraZeneca is a recognized leader in the field of respiratory care, and its inhalation and biologics benefited 53 million patients in 2019. Based on its 50-year history, the company is committed to changing the treatment of asthma and COPD by focusing on early biological research, eliminating preventable asthma attacks and eliminating COPD as the top three major causes of death. The company’s early respiratory research focuses on emerging science involving diseases and neuronal function abnormalities in immune mechanisms, lung damage and abnormal cell repair processes.

With a universal approach across respiratory and immunology and underlying disease drivers, AstraZeneca is following the science of the field from chronic lung disease to immunology-driven disease. The company’s business in the field of immunology continues to grow, mainly in the fields of rheumatology (including systemic lupus erythematosus), dermatology, gastrointestinal diseases and systemic eosinophil-driven diseases. There are five kinds of diseases with multiple diseases. Potential franchise rights in the middle and late stages. AstraZeneca’s ambition in the field of respiratory and immunology is to achieve disease improvement and lasting remission for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a science-led global biopharmaceutical company dedicated to the discovery, development and commercialization of prescription drugs. It is mainly used to treat diseases in the following three areas: oncology, cardiovascular, kidney and metabolism, and respiratory and Immunology. AstraZeneca operates in more than 100 countries/regions, and its innovative drugs have been used by millions of patients worldwide.For more information, please visit www.astrazeneca-us.com And follow us on Twitter @阿斯利康.

US-53643 last updated 5/2021

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