- AstraZeneca plc on Wednesday said the Food and Drug Administration had approved its asthma drug Fasenra, marking the first regulatory OK of a respiratory biologic for the British drugmaker.
- Designed to treat a specific type of severe asthma, Fasenra acts by lowering levels of white blood cells known as eosinophils that can exacerbate inflammation and worsen symptoms. In clinical study, the drug reduced the annual asthma exacerbation rate by more than half versus placebo.
- Another trial showed treatment with Fasenra led to a 75% median drop in daily use of oral corticosteroids, which are often used by asthma patients to manage the condition but can lead to a range of side effects.
Fasenra (benralizumab) is one of three biologics that AstraZeneca has flagged as future growth drivers for its respiratory business, which has seen sales of its top Symbicort (budesonide/formoterol) slow in recent quarters.
Approval will also help AstraZeneca take on GlaxoSmithKline plc's rival Nucala (mepolizumab) and Teva Pharmaceutical Industries Ltd. Cinqair (reslizumab), both of which are approved for similar indications in the U.S.
All three drugs target the interleukin-5 pathway to deplete eosinophil levels, but AstraZeneca believes Fasenra's mechanism of action by binding directly to the 5a receptor helps differentiate its drug.
Additionally, Nucala and Cinqair are approved for 4-week dosing, while Fasenra will be available as a once every 8-week injection after the first three doses.
Eosinophils are a normal part of the immune system, but higher concentrations of the white blood cells can increase the severity of asthma symptoms and decrease lung function. About half of severe asthma patients see elevated levels of eosinophils.
AstraZeneca will sell Fasenra at a wholesale acquisition cost of $38,000 for the first year of treatment, and between $28,000 and $33,000 in subsequent years depending on dose administration dates. The company says the drug will be available in the coming weeks.
In addition to Fasenra, AstraZeneca is developing tralokinumab and tezepelumab, which the British company believes can together form a leading biologics portfolio in respiratory. That will be important as the market for biologics is expected to grow by 8% over the next ten years — a higher rate of growth than for inhaled drugs.
Recent results from a mid-stage study of tezepelumab suggest the drug could offer a more comprehensive approach to treating severe asthma by targeting an upstream cytokine known as thymic stromal lymphopoietin.