AZ’s Bevespi Aerosphere approved in US

AstraZeneca’s (AZ) $1.15 billion bet on Pearl Therapeutics may soon produce returns after lung drug Bevespi Aerosphere (glycopyrrolate+formoterol fumarate) was approved by the US Food and Drug Administration (FDA).

AZ acquired the drug when it bought California-based Pearl in 2013 as it sought to replenish its pipeline as several big-selling drugs lost patent protection.

The drug was approved for 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 bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA).

AZ said the drug is the only LAMA/LABA delivered through a pressurised metered-dose inhaler (pMDI).

The FDA approval is based on the PINNACLE trial programme, which demonstrated the drug achieved statistically significant improvement in morning pre-dose forced expiratory volume in one second at 24 weeks versus its mono-components and placebo.

Bevespi Aerosphere is the first product approved using AZ’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AZ’s respiratory inhaled combination therapies currently in clinical development.

This includes the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010), which also came to AZ from Pearl.

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