AstraZeneca makes a play for asthma market with positive data
- Adding AstraZeneca’s injectable monoclonal antibody, benralizumab, to standard care reduces asthma attacks and improves symptoms in people with severe asthma. Eight-week dosing was as effective as four-week dosing.
- The Phase III data from the SIROCCO and CALIMA trials were presented at the European Respiratory Society (ERS) International Congress, and published in the Lancet on September 4, 2016; they will form part of the U.S. and EU regulatory submissions planned for later in 2016.
- These studies are two of the six Phase 3 trials in the WINDWARD program, reported to be the largest late-stage development program for a biologic medicine in respiratory disease; the Phase 3 program for COPD, VOYAGER, is also under way.
This is AstraZeneca’s first biologic respiratory medicine, and is entering an already established market. GlaxoSmithKline's Nucala (mepolizumab), which also targets eosinophils, has been launched in the U.S., Europe and Japan over the last year. Teva’s eosinophil asthma drug, reslizumab, has been launched as Cinqair in the U.S., and as Cinqaero in Europe. While some people may suggest that AstraZeneca is a little late to the party, its anti-eosinophil monoclonal may only need dosing every two months, compared with monthly doses for Nucala and Cinqair.
Other companies are working on targeted biologics, including Sanofi and Regeneron, who are developing dupilimumab, an IL-4 and IL-13 antibody. Sanofi describes dupilimumab, which is in Phase 3 trials in atopic dermatitis and moderate-to-severe asthma, as one of its “two pillars of a new franchise”. In mid-2016, GlaxoSmithKline licensed in CNTO 7160, an anti-IL-33 monoclonal antibody to treat asthma, from Janssen, to be part of its growing respiratory portfolio.
As well as the risk of life-threatening events, severe asthma also has a major impact on quality of life for people. It means that people can end up relying on oral corticosteroids, which can have unpleasant side effects. The severe exacerbations can result in missed days at school and work, and repeated hospitalizations have an impact on healthcare budgets that are already teetering on the edge in some countries.
Though pharmacoeconomic data hasn’t been published, it’s possible that by reducing hospitalizations, the biologics like benralizumab could potentially save money for healthcare systems. The upside for benralizumab is that it requires fewer doses than the other anti-eosinophil biologics, which is more convenient for patients.
Asthma affects around 315 million people worldwide. While for some people it’s just an inconvenience, for others it can be life-threatening. Up to 10% of people with asthma can have a severe form of the disease, with an eightfold higher risk of death. According to the American Academy of Allergy, Asthma and Immunology (AAAAI), around 250,000 people die prematurely from asthma.
- AstraZeneca Statement
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