- AstraZeneca's new respiratory biologic Fasenra missed its goal in a Phase 3 study of patients with chronic lung disease, throwing into question the British pharma's plans to expand the drug's use beyond its approved indication in asthma.
- When given as an add-on to dual or triple inhaled therapy, Fasenra failed to significantly reduce a type of disease flare-up known as exacerbations. The 56-week trial, called GALATHEA, compared AstraZeneca's drug to placebo in patients with moderate to very severe chronic obstructive pulmonary disease.
- Another, identical Phase 3 study of Fasenra in COPD remains ongoing and AstraZeneca will wait until it has results from both to make a decision on next steps for the drug, the company said in a statement Friday.
Fasenra (benralizumab) is a key part of AstraZeneca's efforts to refresh its respiratory business as the company's mainstay Symbicort (budesonide/formoterol fumarate) franchise ages.
Sales of Symbicort, which accounts for 14% of AstraZeneca's total revenue, dipped 6% last year due to intensifying competition and pricing pressure in the U.S.
AstraZeneca, though, is betting growth in respiratory will increasingly come from biologics rather than inhaled drugs like Symbicort. To that end, the company has focused its research efforts on a crop of three biologics, led by Fasenra.
First approved in November of last year for severe asthma, Fasenra works by targeting a type of white blood cell called eosinophils. While eosinophils are a normal part of the body's immune system, higher concentrations can exacerbate inflammation and worsen disease symptoms.
GlaxoSmithKline's Nucala (mepolizumab) and Teva Pharmaceutical Industries' Cinqair (reslizumab) function in a similar fashion, and entered the market for severe asthma before Fasenra.
Data from Leerink, an investment firm, show Fasenra has made inroads against Nucala since launching in the U.S., but GSK's drug still widely leads AstraZeneca's in total weekly prescriptions.
COPD, which affects 384 million people globally according to AstraZeneca, represents the next target market for Fasenra. The drugmaker has said it expects to submit the drug for U.S. approval in 2019, but the failure of GALATHEA could complicate those plans.
AstraZeneca did not give specific details of the trial's outcome, noting that a full evaluation of the data is still ongoing. Full results will be presented at an upcoming medical meeting, the company said.
The sister study of Fasenra in COPD, meanwhile, is expected to read out later this quarter.
AstraZeneca is also developing a triple combination inhaler for COPD called PT010, which would face stiff competition from GSK's Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) if it reaches market.