NICE backs AZ’ asthma biologic Fasenra

The National Institute for Health and Care Excellence has published draft guidelines recommending the drug as an option for treating the condition when standard therapies - including inhaled corticosteroids and beta-agonists - have failed.

Fasenra (benralizumab) was considered by NICE to be cost-effective only for people who have had at least three exacerbations in the last year, a blood eosinophil count of 400 or more cells per microliter, and only when biological treatment mepolizumab is not appropriate.

AstraZeneca said it is disappointed with this restriction and that is would continue to engage with the Institute to secure access for a wider group of patients.

The firm said it believes that the drug is "a valid treatment option" or patient with a blood eosophinil count of 300 or more cells per microliter and who have had three exacerbations of more in the last year or are taking maintenance corticosteroids.

Fasenra, a monoclonal antibody that recruits natural killer cells to deplete eosinophils, was approved for use in Europe back in January as the first respiratory biologic medicine with an eight-week maintenance dosing schedule.

Approval was based on findings from the WINDWARD programme, including the pivotal Phase III exacerbation trials, SIROCCO and CALIMA, and the Phase III OCS-sparing trial, ZONDA.

Results from SIROCCO and CALIMA showed reductions in the annual rate of asthma exacerbations of up to 51 percent, and an improvement in lung function with a change in FEV1 of up to 159 mL, seen at four weeks after the first benralizumab dose and sustained throughout the treatment period.

Asthma affects 5.4 million people in the UK, and an estimated 5 percent have severe asthma, of which around 50 percent have too many eosinophils (a type of white blood cell) in their lungs, which can cause airway inflammation and lead to asthma symptoms and attacks.

-----------------------------------------------------------------------------------------------------------------------------------------------

Editor's Note:

To apply for becoming a contributor of en-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.