FDA Accepts NDA for Investigational Maintenance Asthma Treatment

The FDA has accepted for review Chiesi’s New Drug Application (NDA) for their investigational maintenance treatment for asthma in adults, according to a recent news release.

The inhaler treatment consists of three active ingredients delivered as a single dose, referred to as a single inhaler therapy treatment. The ingredients are:

• beclomethasone dipropionate, which is an inhaled corticosteroid that reduces inflammation
• formoterol fumarate, a long-acting beta-agonist that relaxes the airways
• glycopyrrolate, an anticholinergic that reduces secretions like saliva

The therapy is administered twice daily using a pressurized, metered-dose inhaler. It is already approved in nearly 50 countries, including the European Union, the United Kingdom and China, marketed under the brand name Trimbow.

“Respiratory care is in our DNA—we have created medicines in this area for more than four decades and transformed respiratory care by creating and commercializing the first triple therapy for asthma outside the U.S. We are bringing our respiratory expertise to the U.S. to help even more people live healthier lives,” Martin Marciniak, vice president of U.S. Medical Affairs at Chiesi, said in the news release.

This NDA acceptance was made using data from the Trimaran and Trigger studies, which evaluated the efficacy and safety of this treatment in more than 2,500 patients with uncontrolled asthma.

In the United States, more than 28 million people have asthma, which is a chronic disease that causes airway inflammation.

Asthma may be triggered by a variety of factors, such as allergens, including seasonal pollen, mold spores and dust. Triggers may also include weather changes, exercise or even strong emotions.

Symptoms such as shortness of breath, wheezing, coughing and chest tightness can be difficult to manage and an estimated 60% of adults with asthma have continued symptoms, despite treatment.

Asthma can also be fatal and expensive for the patient and for the U.S. healthcare system. More than 3,600 adults in the United States die from asthma attacks each year, according to an estimate from the Centers for Disease Control and Prevention. Nearly all asthma-related deaths are preventable with the right treatment and care

From 2008 to 2013, the U.S. healthcare system spent approximately $82 billion on asthma care. Specifically, $3 billion in losses due to missed work or school, $29 billion due to asthma-related mortality and $50.3 billion in medical costs. In 2020 alone, asthma accounted for 94,560 discharges from hospital inpatient care and 986,453 emergency department visits.

Asthma treatment disparities exist as well. In the United States, Black adults have the highest rates of asthma. Asthma is also the most common chronic disease in all children, with non-Hispanic Black children nearly twice as likely to have asthma than non-Hispanic White children.

“Among the 28 million people in the U.S. who have asthma, many experience symptoms that disrupt daily life and have lasting effects on their lung health and function—and tragically, nine people die from asthma complications every day,” Kenneth Mendez, president and CEO of the Asthma and Allergy Foundation of America, said in the news release. “New treatment options offer the potential for improved asthma management. Expanding choices means more opportunities for patients and their care teams to find solutions that meet individual needs and improve quality of life.”