AZ’s Fasenra stumbles in P3 for COPD
pharmafile | May 11, 2018 | News story | Medical Communications, Research and Development | AstraZeneca, Fasenra, GSK, Nucala, biotech, drugs, pharma, pharmaceutical
AstraZeneca’s Fasenra arrived later on the scene than GSK rival med, Nucala, and so it needed to quickly rack up indications to mount a serious challenge – in COPD, at least, that looks more unlikely after the treatment wasn’t able to meet its primary endpoints in a Phase 3 trial.
Fasenra is already approved to treat severe eosinophilic asthma in major markets around the world but was hoping to add to this with an expansion into treating exacerbations in those with moderate to very severe COPD.
Had it succeeded to hit its endpoints, it would have joined GSK in submitting for regulatory approval but now looks set to fall behind, should its rival receive approval.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “COPD is a debilitating disease with significant unmet need among patients whose disease remains uncontrolled despite treatment with existing inhaled therapies. We will now await the results of Terranova and a full evaluation of both trials to determine next steps for Fasenra in COPD.”
GSK did not have a smooth path to acquire the data needed it to submit for approval; in its Metreo study, the drug demonstrated a reduction in exacerbations but not to a level that were statistically significant.
However, it managed to scrape successful results in another trial that was on-going concurrently (Metrex) in reducing exacerbations. It shows that these types of monoclonal antibody treatments can be hit-and-miss in trials for COPD.
Full details were not revealed by AstraZeneca about how far its drug missed the mark but, as mentioned by Bohen, the company has another trial running. If this trial succeeds and the drug only just missed the mark, it could still be emboldened to attempt to file for approval – in a similar manner to GSK.
Fasenra entered the market two years after Nucala but has some advantages that could see it leech GSK’s sales in the area; the product is administered by subcutaneous injection but is delivered every eight weeks (compared to four weeks for Nucala), after a lead-in dosing schedule and is priced at a lower level.
Ben Hargreaves
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