AstraZeneca struck out in May in trying to expand severe eosinophilic asthma drug Fasenra into COPD. But it does have new long-term data that could bolster the drug in its current indication.
On Tuesday, the British drugmaker said that 74% of the patient group that showed the best response to Fasenra in earlier phase 3 trials had seen their lung function and asthma control benefits hold up in the second year of treatment. That 74% also had not experienced any sudden worsening of severe asthma symptoms in the second year of treatment.
Fasenra’s safety and tolerability profile also held up after an additional 56 weeks of treatment, AZ said, noting that researchers didn’t find an increase in the frequency of adverse events.
The data “are important news for patients with severe eosinophilic asthma who need a treatment with sustained efficacy to help control their disease, and with a safety profile that supports long-term use,” AZ R&D head Sean Bohen, M.D., Ph.D., said in a statement.
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They’re also important for the drugmaker, which is duking it out in a field that also features GlaxoSmithKline’s Nucala and Teva’s Cinqair. Nucala, though, is the drug to beat, thanks in part to Cinqair’s less-convenient IV formulation. And the Glaxo product had a major head start, winning its FDA green light more than two years before Fasenra’s late 2017 go-ahead.
Until earlier this year, though, AstraZeneca had hoped to take the Fasenra-Nucala matchup into the COPD arena on a more favorable timeline. It unveiled phase 3 data on Fasenra in COPD just months after GSK filed Nucala for approval in the disease area.
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Problem was, those data weren’t positive—and neither was another set of results that followed just a few weeks later.
Luckily for AZ, though, Glaxo hasn’t been able to break into the COPD arena, either. Last week, the FDA turned away the pharma giant’s application with a request for additional clinical data, preventing it from extending its Nucala lead.