EMA’s human medicines committee (CHMP) has recommended granting an extension of indication to Dupixent (dupilumab) as an add-on maintenance treatment for adult and adolescent (12 years and older) patients with certain forms of severe asthma.
Asthma is a chronic lung disease caused by the interaction of genetic and environmental factors. It causes airways to narrow and swell and produce mucus. The main symptoms are coughing, wheezing, shortness of breath but severe asthma attacks can even lead to hospitalization. Currently, there is no cure for asthma and treatments available are used to control the symptoms (reliever) or to reduce the frequency and severity of the attacks (controller).
Dupixent is a human monoclonal antibody that reduces inflammation observed in the airways through inhibition of the signalling of two key proteins (interleukin-4 and interleukin-13). This represents a novel mechanism of action to the available therapeutic options in severe asthma patients. Dupixent is already approved in the European Union for adult patients with atopic dermatitis who are candidates for systemic therapy. The CHMP’s opinion recommends to extend the indication to add-on maintenance treatment for adult and adolescent (12 years and older) severe asthma patients with type II inflammation characterised by increased blood eosinophils and/or raised exhaled nitric oxide measured by FeNO test and inadequately controlled by inhaled high dose corticosteroids plus another asthma medicinal product.
Therapeutic options are limited for patients with severe asthma whose symptoms cannot be controlled with the available treatments such as high dose inhaled corticosteroids. The benefits and safety of Dupixent have been studied in three pivotal trials including a total of 2,888 patients. In the clinical trials conducted, Dupixent demonstrated benefit to patients by reducing severe asthma exacerbations and improving lung function.
The most common side effects of Dupixent are infections, eye disorders (conjunctivitis and related conditions) and injection site reactions.
The opinion adopted by the CHMP at its February 2019 meeting is an intermediary step on Dupixent’s path to patient access in this new indication. The CHMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation. Once a marketing authorisation has been granted, decisions about price and reimbursement will take place at the level of each Member State, taking into account the potential role/use of this medicine in the context of the national health system of that country.
Source: press release