AstraZeneca’s new severe asthma therapy recommended for EU approval

AstraZeneca has announced that its new severe asthma therapy benralizumab has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended marketing authorisation of benralizumab as an add-on maintenance treatment in adults with severe eosinophilic asthma that remains inadequately controlled, despite treatment with high-dose inhaled corticosteroids and long-acting b-agonists.

Developed alongside AstraZeneca's global biologics research and development arm MedImmune, the drug works by targeting and rapidly depleting eosinophils, and is the first respiratory biologic therapy with an eight-week maintenance dosing schedule.

In the phase III WINDWARD trial programme, the drug demonstrated significant reductions in exacerbations and improvements in lung function, allowing patients to reduce their dependence on oral steroids.

Sean Bohen, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "Benralizumab has the potential to make a real difference to patients with its combination of efficacy, speed of onset, convenience and the ability to reduce oral steroid use."

Benralizumab is also under regulatory review in the US, Japan and several other countries.

With over 20 years of experience within the pharmaceutical market, we at Zenopa have the knowledge, skills and expertise to help find the right job for you. To find out more about the current pharmaceutical roles we have available, you can search for the latest job roles, register your details, or contact the team today.