AstraZeneca Sees Setback as FDA Rejects COPD Drug

AstraZeneca saw a setback in its quest to develop a new drug for chronic obstructive pulmonary disease (COPD). This morning, the U.K. pharma giant announced the U.S. Food and Drug Administration (FDA) rejected its inhaled triple-combination therapy, PT010, now known as Breztri Aerosphere.

The FDA issued a Complete Response Letter for PT010 (budesonide/glycopyrronium/formoterol fumarate), the company said this morning. The New Drug Application was supported by data from the Phase III KRONOS trial. During that trial, AstraZeneca’s data showed that PT010 outperformed its dual therapy rivals eight of nine times. In the KRONOS trial, AstraZeneca pitted PT010 against Bevespi Aerosphere (glycopyrronium/formoterol fumarate), Symbicort Turbuhaler (budesonide/formoterol fumarate) and its investigational PT009 (budesonide/formoterol fumarate) in patients with moderate to very severe COPD regardless of whether or not they had an exacerbation in the prior year.

In its announcement this morning regarding the CRL, AstraZeneca did not specify the concerns raised by the FDA. The company only said it will work closely with the regulatory agency regarding the next steps. That will likely include submission of data from the Phase III ETHOS trial, which had not been completed at the time the NDA was submitted, the company said.

In the ETHOS trial, PT010 demonstrated a statistically-significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). The safety and tolerability of PT010 in the trial were consistent with the known profiles of the dual comparators, AstraZeneca said in August, when the trial data was revealed.

PT010 was approved in Japan in June 2019 as Breztri Aerosphere, a triple-combination therapy to relieve symptoms of COPD. PT010 is under regulatory review in China where it has been granted priority review by the National Medical Products Administration and is also under regulatory review in the European Union.

COPD is a progressive disease that can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 384 million people worldwide and is predicted to be the third-leading cause of death by 2020. About 30 to 40 percent of moderate to severe COPD patients on triple inhaled therapy remain uncontrolled and continue to experience exacerbations. Respiratory drugs have been a key focus for AstraZeneca, particularly since the $575 million acquisition of Takeda Pharmaceutical Company’s core respiratory business, including global rights to roflumilast, a treatment for COPD.

In other AstraZeneca news, the company agreed to sell commercial rights for Losec (omeprazole) and associated brands to Cheplapharm Arzneimittel GmbH for $243 million upfront, with an additional $66 million in potential sales milestone payments. The divestment includes medicines containing omeprazole marketed by AstraZeneca or its collaborators under the Acimax, Antra, Mepral, Mopral, Omepral and Zoltum medicine names, AstraZeneca said. Losec is a proton pump inhibitor discovered and developed by AstraZeneca, which helps to reduce the amount of acid produced by the stomach in patients with gastrointestinal reflux conditions and ulcers. Ruud Dobber, AstraZeneca’s head of biopharmaceuticals, said the divestiture is part of AstraZeneca’s strategy of “reducing the portfolio of mature medicines to enable reinvestment in our main therapy areas.”