FDA OKs AstraZeneca’s COPD Drug
The US Food and Drug Administration has approved AstraZeneca’s Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA). Bevespi Aerosphere is the first product approved using AstraZeneca's co-suspension technology. This technology enables consistent delivery of one or more different medicines from a single pressurized meter dose inhaler (pMDI). The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/inhaled corticosteroid, PT010.
The co-suspension technology uses porous, low-density phospholipid particles, which are designed to form a uniform suspension inside a pressurized metered-dose inhaler (pMDI) and distribution of drug crystals throughout the lungs for release at their sites of deposition. In addition, co-suspension technology addresses issues often seen when multiple drugs are combined in a pMDI. This technology provides a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time and to prevent drug crystals from interacting with one another, thus allowing for consistent dosing of one or more different drugs from a single pMDI, according to information from AstraZeneca.