AstraZeneca, shut out of COPD, touts long-term Fasenra asthma data

AZ's Fasenra competes against GlaxoSmithKline's Nucala and Teva's Cinqair in the severe eosinophilic asthma field. (AstraZeneca)

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.


Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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.

RELATED: AstraZeneca goes to battle with GSK with nod for Nucala challenger Fasenra

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.

RELATED: AstraZeneca's respiratory rivalry with GlaxoSmithKline takes a hit with Fasenra's phase 3 fail

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.

Suggested Articles

Mobile has become universal, accessible, and multi-generational. It’s time for life science brands to revolutionize how they’re telling their story.

Former Retrophin CEO was hoping for a SCOTUS hail mary to escape his seven-year fraud sentences Turns out the court was interest in hearing his plea.

A new investigation shines light on how Purdue pushed back on negative coverage of opioids, placed opioid-friendly experts in think tanks and more.