Severe asthma, new biologic drug approved in Europe
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About 300,000 adults and children suffer from severe asthma in Italy. For them now comes the news of the European approval of a new drug to be used as an additional maintenance therapy in patients from the age of 12. Approval in the European Union follows the recommendation of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of July 2022.
Severe asthma
This pathology has a significant impact on the patient’s daily life from a physical, psychological and work point of view. Estimates indicate that among asthma patients – about 3 million in Italy – up to 10% develop a severe form of the disease. “Severe asthma is a highly under-diagnosed disease that affects up to 10% of asthmatic patients and its complex and heterogeneous nature means that those who suffer from it suffer a significant impact on their daily life from multiple points of view: physical, psychological, social and occupational “, explains Simona Barbaglia, president of the National Association of Patients Breathing Together.
The problem of exacerbations
One of the most common problems among patients with severe asthma is that of exacerbations. “As part of the daily support that we offer to patients – continues Barbaglia – we have found that the greatest difficulty is the fact that multiple external factors can generate symptoms and exacerbations, making the disease difficult to control, an aspect that can complicate its management and consequent choice of the correct treatment path. This has a strong impact on the way patients carry on their daily lives and it is therefore of great importance to have a new therapeutic option available to help these patients better control their severe asthma and improve the quality of their lives ”.
The new drug
Tezepelumab has been approved in the European Union as maintenance adjunct therapy in patients 12 years of age and older with inadequately controlled severe asthma despite using high-dose inhaled corticosteroids in addition to another control drug. “This new indication represents a major breakthrough in the treatment of patients with severe asthma,” he says Giorgio Walter Canonica, Extraordinary Professor of Respiratory Medicine, Humanitas University; Head of Personalized Medicine Center: Asthma and Allergology, Humanitas Research Hospital, Rozzano (MI).
The action on the inflammatory cascade
Tezepelumab is the first and only biological drug approved in Europe for severe asthma to act at the start of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine. “Patients with severe asthma have multiple disease drivers and tezepelumab is the only biological drug able to act at the beginning of the inflammatory cascade by inhibiting the interaction between the epithelial cytokine TSLP and its receptor and therefore independently of the polarization of the inflammatory response “.
Studies
The European Commission approval is based on the positive results of the PATHFINDER clinical trial program, which includes the Phase III study NAVIGATOR, which demonstrated the superiority of tezepelumab over placebo, in all primary and secondary endpoints in asthma patients. severe when added to the standard of care. “Even in light of the results of the Phase II and III clinical trials that demonstrated that tezepelumab statistically significantly reduced the rate of exacerbations in patients, the European approval of tezepelumab provides a relevant opportunity to improve the management of affected patients. from severe asthma and we hope that it will soon become a concrete reality also in Italy ”, concludes Canonica. The results of the Phase III NAVIGATOR Study were published in May 2021 on The New England Journal of Medicine.
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