In its heated severe asthma fight with AstraZeneca’s Fasenra, GlaxoSmithKline could take solace in the fact that its drug was more convenient for patients, with a self-administered injection option. But that’s not the case anymore now that Fasenra has picked up a nod for an at-home application of its own.
The FDA approved Fasenra as a prefilled auto-injector, called the Fasenra pen, meant to be taken every eight weeks, AstraZeneca said.
Nucala, though, will still have an edge in terms of at-home options: Both drugs are now approved as an auto-injector, but Nucala also has a nod for a prefilled syringe that can be administered at home. Currently, Fasenra’s own prefilled syringe must be administered by a healthcare professional in a clinical setting.
With an at-home administration approval in hand, Fasenra will keep the pressure on Nucala as the two compete for dominance in severe eosinophilic asthma.
Earlier this week, Nucala scored a real-world win with phase 3 data showing the drug cut severe eosinophilic asthma attacks by 69% as an add-on treatment to corticosteroids.
Patients in the study, dubbed Realiti-A, had taken only standard-of-care corticosteroids for 12 months before enrolling in the trial. Nucala also showed it could reduce the rate of exacerbations leading to hospitalizations and emergency room visits by 77%, and it allowed 34% of patients taking standard-of-care corticosteroids to stop using them, GSK said.
Fasenra, for its part, holds clinical data showing patients who used the med continuously for up to two years used fewer oral corticosteroids, saw fewer episodes where symptoms suddenly worsened, and had better lung function, asthma control and quality of life compared with patients on placebo.
AstraZeneca pinned high hopes on fast-growing Fasenra, but its failure to post positive data in chronic obstructive pulmonary disease (COPD) hurt the drug's sales prospects. The company felt that miss even harder earlier this week after its triple-drug COPD hopeful Breztri failed to garner FDA approval. That drug, chasing after GSK’s Trelegy, was positioned as AstraZeneca’s next step in its respiratory portfolio.
For now, AstraZeneca will have to take solace in Fasenra’s $296 million in first-half sales—a 244% increase over the same period in 2018.
And the COPD miss doesn't mean there isn't room for different label expansions. In August, Fasenra scored an FDA designation as an orphan drug for eosinophilic esophagitis, an ultra-rare disease that currently has no approved treatments. The designation comes with seven years of exclusivity, apart from patent protection, among other benefits. A phase 3 trial in June showed Fasenra halved blood eosinophil counts in patients with hypereosinophilic syndrome, another ultra-rare condition. Only 30% of patients taking placebo in the study reached that mark.