One of the global Biopharma Majors, AstraZeneca has recently announced that their Biologics License Application (BLA) for Tezepelumab has been granted Priority Review by the US FDA. This acceptance of Priority Review is for the treatment of Asthma. As per the company’s recent press release, Tezepelumab which is developed in collaboration with Amgen is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials. The biological medicines available in the segment are not suitable to many patients. Asthma patients experiencing frequent exacerbations do not qualify for many medications available in this segment. Tezepelumab which had already received Breakthrough Therapy Designation in 2018 holds promise in patients with severe Asthmatic conditions.
Difficult to treat Asthma associated with severe and frequent exacerbations
An article published in European Respiratory Journal in 2005 has referred to the recurrent exacerbations as the cause of morbidity in patients with Asthma. This article also highlights five specific factors that can potentially cause frequent exacerbations. Those factors include severe nasal sinus disease, gastro-oesophageal reflux, recurrent respiratory infections, psychological dysfunctioning and obstructive sleep apnoea. These conclusions were drawn based on the study of 136 patients with difficult to treat Asthma. The clinical investigations in that study could lead to some changes in the treatment protocols.
Identifying and treating the conditions or factors that eventually cause exacerbations has been the conventional approach. However, the lack of specific treatment for reducing asthma exacerbation always remained a challenge. Various advanced treatment options for Asthma could not address this challenge. Tezepelumab’s FDA approval may potentially fill this void and significantly benefit the patients with severe asthmatic conditions.
Clinical research data to establish Tezepelumab demonstrated superiority
AstraZeneca’s press release in February 2021 about the pivotal NAVIGATOR Phase III trial focused on the positive full results presented at the American Academy of Asthma Allergy & Immunology Virtual Annual Meeting. The results indicate a statistically significant reduction of AAER, the parameter referred to evaluating the asthma exacerbation. AAER stands for annualized asthma exacerbation rate. As per the clinical trial outcomes, there is 56% reduction in AAER when Tezepelumab is added to the standard of care, considered as clinically meaningful reduction. The drug also meets the key secondary end points. That includes statistically significant improvement in terms of lung function measurements, asthma control and health-related quality of life. This Phase III trial results that eventually became the basis for regulatory approval considerations are termed unprecedented by noted clinical research experts.
Asthma is a severe healthcare challenge for patients and physicians across the world, including the USA. It is estimated that approximately 25 Million Americans have respiratory diseases that include Asthma. It is also a leading condition when it comes to chronic diseases among children. Over 5 Million children in the US (below 18 years) are estimated to have Asthma. As per healthline, acute severe asthma accounts to 3.6% of all adults with Asthma. They are susceptible to frequent exacerbations. Tezepelumab certainly offers hope.
