Ok Chmp Ema to monoclonal Gsk for 3 eosinophil diseases

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Ok Chmp Ema to monoclonal Gsk for 3 eosinophil diseases

It is a monoclonal antibody and could become the “first targeted treatment available for use in 4” diseases caused by eosinophils. The drug mepolizumab targets interleukin-5 (Il-5) and today received the positive opinions of the Committee for Medicinal Products for Human Use (Chmp) of the European Medicines Agency Ema which recommended it for 3 type pathologies eosinophilic: hypereosinophilic syndrome and eosinophilic granulomatosis with polyangiitis (Hes and Egpa), both potentially life-threatening rare diseases, and chronic rhinosinusitis with nasal polyps.

This was announced by GlaxoSmithKline, recalling that the CHMP opinion is one of the final stages of the marketing authorization procedure, before the approval decision by the European Commission. The 3 positive opinions – explains the British company in a note – are based on data from as many studies that analyze the role of the targeted inhibition of Il-5 with mepolizumab in these diseases caused by eosinophils, inflammatory conditions associated with high levels of eosinophils, a type of white blood cell.

He is pleased with the positive opinions of Chmp Christopher Corsico, Senior Vice President of Development of GSK. “Currently – he says – there are limited targeted treatment options for patients in Europe with eosinophil-induced disease. If approved, mepolizumab would be the first targeted treatment available for use in 4 of these diseases.” Mepolizumab is already approved for use in Europe as an adjunct treatment for patients with severe eosinophilic asthma, “and would further strengthen its role in targeting the underlying cause of the inflammation.”

In Hes and Egpa diseases – underlines Gsk – inflammation in various tissues can cause a series of often severe symptoms. The standard of care for these conditions often still includes oral corticosteroids and / or cytotoxic immune therapies. The availability of mepolizumab could provide patients with a new treatment option with the potential to improve clinical symptoms and reduce the use of oral corticosteroids.

The third condition for which Ema’s CHMP was positive is a condition (Crswnp) in which patients may develop soft tissue growths called nasal polyps, which can cause chronic symptoms such as nasal obstruction, loss of smell and discharge. . In severe disease, patients may require repeated surgery due to recurrent growths. Epidemiological, clinical and pathophysiological studies strongly suggest that Crswnp and asthma are closely linked and often coexist. Additionally, patients with Egpa often have severe asthma. This overlap between the diseases characterized by eosinophils highlights – the note continues – the importance of understanding the complex role of eosinophils in the disease.

Mepolizumab has been studied in over 4,000 patients in a total of 41 clinical trials that investigate the role the drug may play in targeting the underlying cause of inflammation and reducing eosinophils through IL-5 inhibition.

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