FDA News

Triple therapy fails to win FDA approval for COPD

The FDA has issued a complete response letter regarding the new drug application for PT010 — an inhaled triple-combination therapy — for COPD, according to a press release from the manufacturer.

The new drug application for PT010 (AstraZeneca), which combines budesonide, glycopyrronium and formoterol fumarate, included data from the phase 3 KRONOS trial. AstraZeneca said in the release that it will now work closely with the FDA on the next steps, including submitting for review recent results from the phase 3 ETHOS trial, which showed that the triple-combination therapy significantly reduced moderate or severe exacerbations when compared with two dual therapies. ETHOS had had not yet been completed when the application was submitted.

PT010 was recently approved in Japan as Breztri Aerosphere to relieve COPD symptoms and is under regulatory review in China and the European Union.

The FDA has issued a complete response letter regarding the new drug application for PT010 — an inhaled triple-combination therapy — for COPD, according to a press release from the manufacturer.

The new drug application for PT010 (AstraZeneca), which combines budesonide, glycopyrronium and formoterol fumarate, included data from the phase 3 KRONOS trial. AstraZeneca said in the release that it will now work closely with the FDA on the next steps, including submitting for review recent results from the phase 3 ETHOS trial, which showed that the triple-combination therapy significantly reduced moderate or severe exacerbations when compared with two dual therapies. ETHOS had had not yet been completed when the application was submitted.

PT010 was recently approved in Japan as Breztri Aerosphere to relieve COPD symptoms and is under regulatory review in China and the European Union.