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(Alliance News) - AstraZeneca PLC on Wednesday posted positive results from its phase three trial of Breztri Aerosphere and said Fasenra has been granted orphan drug designation in the US.
The phase 3 trial of Breztri Aerosphere in COPD met its primary endpoint, demonstrating "a statistically-significant reduction in the rate of moderate or severe exacerbations" when compared to the dual-combination therapies Bevespi Aerosphere and PT009.
Breztri Aerosphere is a combination of budesonide, glycopyrronium, and formoterol fumarate.
The study found a statistically significant reduction in the rate of severe to moderate exacerbations both at the standard budesonide dose and at a half dose of budesonide versus dual-combination therapies.
Mene Pangalos, executive vice president of biopharmaceuticals research & development at AstraZeneca, said: "Exacerbations are devastating events for patients and can lead to a permanent loss of lung function. The phase 3 Ethos trial builds on the phase 3 Kronos data which together show Breztri Aerosphere's ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months. We look forward to sharing these results with health authorities as soon as possible."
So far, Breztri Aerosphere has been approved in Japan and is under regulatory review in China. Regulatory review of the drug is also taking place in the US and EU.
Also on Wednesday, Astra announced that the US Food & Drug Administration has granted Fasenra orphan drug designation as a treatment for eosinophilic oesophagitis. Oosinophilic oesophagitis is a rare and chronic disease caused by the accumulation of a type of white blood cells called eosinophils build up in the oesophagus and cause inflammation and injury.
The FDA grants orphan drug designation status to drugs which treat, prevent, or diagnose rare diseases affecting less than 200,000 people in the US.
Pangalos also commented on the Fasenra designation, he said: "Eosinophilic oesophagitis is an allergic inflammatory disease that can affect children and adults, and typically patients experience a range of debilitating symptoms including severe pain and difficulty swallowing food. Currently there are no FDA-approved treatments for eosinophilic oesophagitis. Because Fasenra depletes eosinophils in blood and tissue, it could become a potential new medicine to treat patients with this rare disease."
Shares in Astra were marginally lower at 7,238.00 pence in London on Wednesday morning.
