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AstraZeneca PLC on Thursday reported several positive developments in its pipeline, including its breast cancer drug clearing another regulatory hurdle, and positive phase III trial results for Farxiga and Ultomiris.
In the latest regulatory win for the Cambridge, England-based pharmaceutical company, its breast cancer drug Enhertu has been approved by the US Food & Drug Administration for the treatment of unresectable or metastatic human epidermal growth factor receptor 2-positive breast cancer.
This follows Enhertu receiving breakthrough therapy designation in late April for patients with unresectable or HER2-low metastatic breast cancer.
Enhertu, generically trastuzumab deruxtecan, is a HER2-directed antibody drug conjugate, developed by AstraZeneca in partnership with Tokyo-based peer Daiichi Sankyo Co Ltd. The approval covers patients who have already received a prior anti-HER2-based regimen, either in the metastatic setting, or in the neoadjuvant or adjuvant setting.
In other positive news, Farxiga, or dapagliflozin, met the primary endpoint in the Deliver phase III trial. The drug showed statistically significant and clinically meaningful reduction in cardiovascular death or worsening heart failure. The trial ran on patients who have heart failure with mildly reduced or preserved ejection fraction.
Ejection fraction is a measure of how much blood the left ventricle pumps out with each contraction.
Farxiga is a sodiumglucose co-transporter 2 inhibitor, which is already approved for the treatment of type 2 diabetes, chronic kidney disease and heart failure with reduced ejection fraction.
Regulatory submissions for Farxiga will be made in the coming months, AstraZeneca said.
Thirdly, AstraZeneca noted positive high-level results from the Champion NMOSD phase III trial for Ultomiris, or ravulizumab-cwvz, which met its primary endpoint. The drug achieved a meaningful reduction in the risk of relapse in patients with a specific type of neuromyelitis optica spectrum disorder.
NMOSD is an autoimmune disease that affects the central nervous system, including the spine and optic nerves. It can cause relapses and worsening of neurologic symptoms, which can be severe enough to result in permanent disability.
No relapses were observed in 58 patients over an average treatment period of 73 weeks, AstraZeneca noted.
Data from the Champion trial will be presented at an upcoming medical meeting and to global health authorities as quickly as possible, the company said.
Shares in AstraZeneca were up 0.6% to 10,564.00 pence each in London on Thursday morning
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