The inhaler administers three active ingredients through a single device, known as single inhaler triple therapy (SITT), which has already received approval in nearly 50 countries.
It combines formoterol fumarate (FF), a long-acting beta-agonist; glycopyrrolate (G), an anticholinergic; and beclomethasone dipropionate (BDP), an inhaled corticosteroid.
Chiesi US Medical Affairs vice-president Martin Marciniak said: “The FDA’s acceptance of Chiesi’s NDA for our fixed-dose triple combination inhaler represents another important step in our journey to delivering solutions that address respiratory needs and reduce the burden that persists for people living with asthma, their caregivers, and the healthcare system in the US.
“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 commercialising the first triple therapy for asthma outside the US. We are bringing our respiratory expertise to the US to help even more people live healthier lives.”
The inhaler is to be administered two times a day using a pressurised metered-dose inhaler (pMDI).
The NDA is supported by data from the TRIGGER and TRIMARAN studies, which are active-controlled, randomised, parallel-group, double-blind Phase III trials.
These studies evaluated the efficacy and safety of the ingredients in the triple inhaler in over 2,500 subjects with uncontrolled asthma.
The single inhaler triple therapy pressurised metered dose inhaler was the first of its class to receive approval outside the US and is currently marketed in several countries, including China, the European Union, and the UK.