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AstraZeneca New drug: Fasenra for severe eosinophilic asthma
AstraZeneca New drug: Fasenra for severe eosinophilic asthma. AstraZeneca Fasenra in the treatment of severe eosinophilic asthma: shows long-term safety and effectiveness over 5 years!
AstraZeneca recently announced the results of a new comprehensive analysis at the American Thoracic Society (ATS) 2021 International Conference, including data from the anti-inflammatory drug Fasenra (benralizumab) for the treatment of asthma in the MELTEMI Phase 3 open-label extension trial . The analysis showed that Fasenra was well tolerated for up to 5 years, and its long-term safety was consistent with previous Phase 3 trials in adults with severe asthma. During the open-label period, at least 75% of Fasenra-treated patients with elevated blood eosinophil levels did not experience asthma exacerbations each year.
During the extended trials of BORA and MELTEMI, Fasenra did not increase the incidence of adverse events (AE) and serious adverse events (SAE) compared with placebo compared to those observed in the key Phase III trial. The incidence of severe infection, hypersensitivity, immunogenicity and malignant tumors in all treatment groups was low, and there were no deaths during the treatment period. During the open-label period, among patients receiving Fasenra every 8 weeks, the most common adverse reactions were nasopharyngitis, asthma, headache, and bronchitis. These data confirm Fasenra’s good safety status.
In terms of secondary endpoints, Fasenra maintained the reduction in asthma exacerbation rates observed in the previous Phase III trials of SIROCCO, CALIMA, ZONDA, and BORA. During the 5-year treatment period, the annualized asthma exacerbation rate (AAER) has been maintained at a relatively high level. Low level.
In patients who were treated with Fasenra every 8 weeks and took high-dose inhaled corticosteroids (ICS) with blood eosinophil levels ≥300 cells/μl, AAER decreased from 3.1 asthma exacerbations/year before treatment to The 0.5 in the previous study further dropped to 0.2 in the fourth year of the open label trial. In the same treatment group, 59% of patients did not get worse during the open-label period (BORA and MELTEMI) within 4 years, and at least 75% of patients did not experience asthma exacerbations each year. In the last year of the trial, 87% of patients did not experience asthma exacerbations.
The lead investigator of the MELTEMI study, Arnaud Bourdin, Professor of Respiratory Medicine and Director of Pulmonology at Arnaud de Villeneuve Hospital in Montpellier, France, said: “Clinicians who treat severe eosinophilic asthma want to make sure that the treatment they prescribe will continue to help. Patients have long-term control of the disease and have consistent safety. According to the latest data from the MELTEMI study, doctors and their patients should believe that Fasenra provides a treatment plan that can do this—reducing with known safety Asthma gets worse.”
AstraZeneca’s Fasenra global franchise leader Mark White said: “The new data from the MELTEMI study are exciting because they confirm the efficacy and safety of Fasenra in the previously reported phase three trials. These results should be provided to doctors and patients. With further confidence, the positive results they experienced when using Fasenra can be maintained for a long time.”
The active pharmaceutical ingredient of Fasenra is benralizumab, which is a monoclonal antibody that can directly bind to the α subunit of the interleukin 5 receptor (IL-5Rα) on eosinophils, and uniquely attracts natural killing of cells ( NK cell), which induces rapid and almost complete depletion of eosinophils through apoptosis (programmed cell death).
At present, Fasenra has been approved in the United States, the European Union, Japan and other countries as an additional maintenance therapy for the treatment of severe eosinophilic asthma. In addition, the Fasenra self-medication option has also been approved by the United States and the European Union for self-administration by patients with a new pre-filled, disposable auto-injector (Fasenra pen).
Fasenra is licensed by AstraZeneca from BioWa, a wholly-owned subsidiary of Kyowa Hakko Kirin, a Japanese pharmaceutical company. At the end of March 2020, AstraZeneca and Concord Fermented Kirin signed a new agreement to obtain the Asian rights for all indications of Fasenra. In addition to the approved indications for eosinophilic asthma, AstraZeneca is also evaluating Fasenra for the treatment of 8 eosinophil-driven diseases, including: severe nasal polyps, eosinophilic esophagitis (EoE), and hypereosinophilia Acidic granulocytic syndrome (HES), eosinophilic granulomatous polyangiitis (EGPA), chronic obstructive pulmonary disease (COPD), etc. Previously, the FDA has granted Fasenra the orphan drug designation for the treatment of EoE, HES, and EGPA.
(source:internet, reference only)