Circassia’s COPD Treatment Approved by FDA

Circassia Pharmaceuticals, a British company with U.S. headquarters in Morrisville, has received U.S. Food and Drug Administration approval of Duaklir Pressair, a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD).

Duaklir Pressair is a fixed-dose combination of the long-acting muscarinic antagonist (LAMA) aclidinium bromide and the long-acting beta agonist (LABA) formoterol fumarate.  It is administered twice daily using a pre-loaded, breath-actuated, Pressair multi-dose inhaler. 

The drug’s approval gives COPD patients “a new, effective and safe option in LAMA/LABA therapy, enabling them to receive maximal improvement in lung function delivered through a unique dry-powder inhaler,” said Michael Asmus, Circassia’s vice president of U.S. medical affairs.

The product is approved worldwide, including in the European Union, under various brand names.

Circassia has exclusive U.S. commercialization rights to Duaklir Pressair under a 2017 commercial collaboration with AstraZeneca, which is responsible for the product’s development and regulatory submission. Circassia also has the commercial rights to another COPD treatment, Tudorza Pressair.

“Our collaboration with AstraZeneca throughout the Duaklir Pressair regulatory process has been overwhelmingly positive,” said David Acheson, Circassia’s senior vice president of U.S. commercial. “We look forward to bringing Duaklir Pressair to market in the coming months as an important expansion of Circassia’s COPD and respiratory health portfolio.”

The FDA approval is based on data from several studies including a Phase 3 clinical trial, called AMPLIFY, that compared the efficacy and safety of inhaled Duaklir Pressair to its individual components, aclidinium and formoterol, in 1,583 patients with moderate-to-very-severe symptomatic COPD. 

The trial found that Duaklir Pressair significantly improved lung function versus aclidinium and formoterol.

“The results of the AMPLIFY trial showed us that the benefits of the combination were more than its individual components in terms of efficacy, with a comparable safety profile,” said Sanjay Sethi, M.D., professor and chief of pulmonary, critical care and sleep medicine at the University of Buffalo’s Jacobs School of Medicine & Biomedical Sciences, and an investigator on the AMPLIFY trial. 

“The study also showed a reduction in the use of rescue inhalers in the Duaklir Pressair group, which is a good measure of symptom control in symptomatic COPD patients,” Sethi said.  “Duaklir Pressair will be a welcome addition to the armamentarium to help these patients.”

The findings of the AMPLIFY trial were published online in the March 22 edition of the International Journal of COPD.

Prevalence of COPD is growing

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure. The most common symptoms are breathlessness, chronic cough and sputum production.

COPD can lead to serious long-term disability and early death, and the number of people dying from the disease is growing. It is the third leading cause of death in the United States, according to the American Lung Association. 

More than 11 million people have been diagnosed with COPD, and millions more may have the disease without knowing it.

Circassia focused on respiratory disease

Circassia is a specialty pharmaceutical business focused on respiratory disease.  It sells its NIOX asthma-management products directly to specialists in the United States, the United Kingdom, China and Germany, and in other countries through its network of partners.

Circassia was established in 2006 and has global headquarters in Oxford, England. In 2014 it completed an initial public offering of stock on the London Stock Exchange.

The company moved its U.S. headquarters from New Jersey to Morrisville in 2012 with financial incentives provided by the Town of Morrisville and assistance from other local partners including the North Carolina Biotechnology Center, the N.C. Department of Commerce, the N.C. Community College System, Wake County and the Morrisville Chamber of Commerce.

At the beginning of this year, the Morrisville site employed about 50 people in management, customer service, accounting, marketing, training and other administration.