- AstraZeneca no longer plans to seek approval of its new respiratory biologic Fasenra in chronic obstructive pulmonary disease (COPD) after the second of two Phase 3 trials showed the drug failed to significantly reduce flare-ups of the lung condition.
- "These results are disappointing because uncontrolled COPD patients already on dual or triple inhaled therapy need new treatment options," said AstraZeneca's Chief Medical Officer Sean Bohen in a May 30 statement, indicating the company would further analyze data from the two studies.
- The British pharma announced the failure of the first Phase 3 study earlier this month. Together, the trials were meant to support expanded use of the drug, which is currently approved for severe asthma.
The setback in COPD hurts Fasenra (benralizumab)'s future market prospects, clouding what AstraZeneca has called a strong start for the drug in severe asthma.
Approved in mid-November last year, Fasenra earned $21 million in sales over the first three months of the year — $19 million of which came from the U.S. market.
"Fasenra is off to a very encouraging start and already gaining market share of new patients compared to other available medicines targeting the IL-5 pathway in severe eosinophilic asthma," said AstraZeneca CEO Pascal Soriot on a recent earnings call.
Those rival medicines include GlaxoSmithKline's Nucala (mepolizumab) and Teva Pharmaceutical Industries' Cinqair (reslizumab), both of which have been on the market for several years.
Market data collected by Leerink, an investment firm, show Fasenra recently edged out Nucala in share of new-to-brand prescriptions, although the GSK drug widely leads AstraZeneca's in total prescriptions.
But missing in COPD could put AstraZeneca behind its rivals. GSK has submitted Nucala for U.S. approval in COPD and expects an OK to come sometime this year.
AstraZeneca is also facing pressure elsewhere in its respiratory business, which posted a 6% drop in sales for the first quarter. Competition and pricing pressures weighed on Symbicort (budesonide/formoterol), while supply issues in China hurt Pulmicort (budesonide) sales.
The company did not indicate whether it would drop development of Fasenra in COPD entirely but — for now at least — any plans appear to be on hold until further review of data from the two trials.
An experimental candidate, called PT010, could help fill the gap, though. AstraZeneca expects to submit the three-drugs-in-one inhaler, which succeeded in Phase 3 this past January, for approvals in several markets later this year and in 2019.