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Circassia submits US FDA applications for 2 lung disease medicines

Circassia Pharmaceuticals PLC submitted applications to the U.S. Food and Drug Administration for Duaklir Pressair and Tudorza Pressair, which are treatments for a lung disease.

The U.K.-based company bought the U.S. commercialization rights to Duaklir and Tudorza from AstraZeneca PLC in 2017. Pressair is the multidose inhaler used to administer the drugs.

The new drug application for Duaklir Pressair covers the treatment of chronic obstructive pulmonary disease, or COPD, and is supported by data from several clinical trials. The drug is approved to treat COPD in about 50 countries.

The supplemental new drug application for Tudorza Pressair covers an update to the drug's prescribing information, particularly with data from a recent, successful phase 4 trial that showed the medicine reduced exacerbations, or worsening of disease, with no increase in heart-related adverse events.

Tudorza is already approved by the FDA to treat COPD, a progressive lung disease that cause breathlessness and affects an estimated 30 million people in the U.S.

AstraZeneca owns 19.9% of Circassia.