- AstraZeneca plc's triple combination inhaler for chronic lung disease beat out a trio of two-in-one drugs in the Phase 3 KRONOS study, giving the big pharma a boost as it works to reinvigorate its respiratory business.
- Topline results announced Friday indicate AstraZeneca's PT010 met six out of the study's seven lung function primary endpoints, which were based on how much air patients could exhale in one second. KRONOS pitted PT010 against AstraZeneca's dual combo medications Symbicort Turbuhaler, Bevespi Aerosphere and PT009 in patients with chronic obtrusive pulmonary disease (COPD).
- AstraZeneca expects to file PT010 for approval in Japan and China in the back half of 2018, and hopes to wrap up U.S. and European submissions in 2019. The company intends to present more detailed data from KRONOS at a future medical meeting, according to a Jan. 26 statement.
CORRECTION: After publication of this article, AstraZeneca amended its release on the KRONOS study to clarify that PT010 met six out of seven lung function primary endpoints and eight of nine total primary endpoints, including two non-inferiority endpoints to qualify PT009.
Over the first nine months of 2017, sales from AstraZeneca's portfolio of respiratory drugs fell 5% year over year to $3.37 billion. The U.K.-based drugmaker pointed to "pressures" in the U.S. — surely meaning increased competition in the COPD space — for a weaker performance from its flagship Symbicort (budesonide/formoterol) franchise, which fell 9% from the same period in 2016.
In September, GlaxoSmithKline plc secured the first Food and Drug Administration approval for a once-daily, three-in-one inhaler for COPD. The drug, named Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), will enjoy at least a year on the U.S. market before AstraZeneca's PT010 gets a chance at entering.
The approval not only gives GSK a head-start in locking down physician and payer support, but also gives it an advantage when it comes to dosing. While Trelegy Ellipta is OK'd for once-a-day use, the KRONOS study is evaluating PT010 on a twice-daily regimen.
AstraZeneca didn't report specific figures or outcomes from KRONOS other than PT010 met almost all the primary lung function endpoints. The only one it didn't meet was at 24 weeks versus Bevespi Aerosphere (glycopyrrolate/formoterol fumarate), though there was a "favorable trend," according to the Jan. 26 statement.
When those data come out, it will be clearer how well AstraZeneca's drug can really stack up to GSK's. In the meantime, AstraZeneca has high hopes for its recently approved asthma biologic Fasenra (benralizumab), which the company predicts to be a future growth driver for its respiratory business.
"With the KRONOS trial, we are seeing the potential of PT010 as a triple combination therapy for COPD," Klaus Rabe, professor of pulmonary medicine at the University of Kiel and national coordinating investigator of the KRONOS trial, said in a Friday statement.
"I expect the triple class of medicines to play an increasingly important role in addressing the needs of the many COPD patients who are currently undertreated or are receiving triple combination therapy as separate medicines in multiple devices," he said.