AstraZeneca’s ambitions for keeping pace with GlaxoSmithKline in the severe COPD market just took a big hit.
In a late-stage COPD trial released Friday, the British drugmaker’s blockbuster hopeful Fasenra didn’t beat placebo at holding off episodes when symptoms suddenly worsen. The study, dubbed Galathea, examined the drug as an add-on to dual- or triple-inhaled therapy.
AstraZeneca isn’t throwing in the towel yet, though. It’s still fielding one more phase 3 study, Terranova, and “we will now await the results … and a full evaluation of both trials to determine next steps for Fasenra in COPD,” R&D chief Sean Bohen said in a statement.
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It’s not the first time Fasenra has failed to improve COPD exacerbation rates. Back in 2014, the drug missed its primary endpoint in a phase 2a study. In that 101-patient trial, Fasenra also fell short against placebo at cutting down the rate of those episodes.
Meanwhile, chief rival GlaxoSmithKline—which markets first-in-class IL-5 therapy Nucala—is waiting for an FDA decision in COPD after posting positive exacerbation-rate data of its own. In a phase 3 study, Nucala topped placebo at paring down the frequency of moderate and severe episodes in patients with higher blood eosinophil counts, a biomarker targeted by this class of drugs.
Despite Nucala’s two-year market lead, AstraZeneca has been pushing full steam ahead to catch up with Fasenra. The company has poured resources into the med’s launch in severe eosinophilic asthma, and figures the rollout will be “very, very competitive” in terms of “field force size, marketing dollars, educational dollars,” company respiratory VP Tosh Butt said last year.
Glaxo is busy itself, though. In December, it scored an FDA nod to treat eosinophilic granulomatosis with polyangiitis (EGPA), a chronic rare disease caused by inflammation in the walls of blood vessels. And the company is testing the product in areas such as nasal polyps, too.
May 12, 2018