FDA Approves TEZSPIRE® for Self-Administration in Severe Asthma Patients Aged 12+

Amgen and AstraZeneca announced today that TEZSPIRE® (tezepelumab-ekko) has received approval from the U.S. FDA for self-administration in a pre-filled, single-use pen for severe asthma patients aged 12 and above. This approval is a breakthrough in the treatment of severe asthma. It sets TEZSPIRE apart as the only biologic approved for treating severe asthma without any phenotype or biomarker restrictions in its label.

Publish Date: 02-02-2023 Source: Amgen

Asthma is a chronic inflammatory condition of the airways in which hypertrophy of bronchial smooth muscle and mucous glands with plugging of small airways with thick mucus can occur. This airway inflammation contributes to airway hyper-responsiveness, airflow limitation, and respiratory symptoms and is at the root of the disease’s chronic nature. Based on the clinical features classified as mild intermittent, mild persistent, moderate persistent, or severe persistent, depending on symptom frequency and severity and lung function as assessed by forced expiratory volume in 1 second (FEV1). Depending on symptoms, signs, and functional assessment, asthma exacerbations are classified as mild, moderate, severe, and impending respiratory failure.

The incidence of Asthma in the USA varies from 158 to 187 cases per 100,000 population, and the prevalence varies between 6.7 to 8.5 across all ages.

However, the current Asthma treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Benralizumab, GSK3511294, Flovent®, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Asthma treatment. The key companies in the advanced development stage are AstraZeneca, GlaxoSmithKline, Actavis Inc., etc.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Asthma to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

About Thelansis:

Thelansis specializes in pharmaceutical market outlook and market forecast reports. We published reports across the therapeutic area, including rare / ultra-rare and mainstream indications. Over the period, we have built a robust repository of 6,000+ Bio-pharma reports that cover Epidemiology studies and Market forecasting based on the KOL opinions.

Competitive intelligence and track of trial results throughout the phases of development executed by a team of a mix of Scientific and Business backgrounds. As an organization, the primary focus is to provide real-world data evidence and market insight to pharmaceutical companies for their decision-making.