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(Correcting the description of extravascular haemolysis' effects on patients with paroxysmal nocturnal haemoglobinuria)
(Alliance News) - AstraZeneca PLC on Tuesday noted significant progress for two of its clinical-stage treatments in the US.
The Cambridge, England-based pharmaceutical company said that its Voydeya treatment had been granted approval by the US Food & Drug Administration.
The FDA green-lit Voydeya as an add-on treatment for extravascular haemolysis in adults with paroxysmal nocturnal haemoglobinuria.
Extravascular haemolysis is the abnormal destruction of red blood cells outside the blood vessels. A small subset of patients living with PNH who are treated with a C5 inhibitor can experience significant effects of the condition, resulting in symptoms of anemia and potentially requiring blood transfusions.
AstraZeneca said that the approval was based on positive results from phase III trials, which demonstrated that Voydeya, in combination with ravulizumab or eculizumab, "significantly improved haemoglobin concentrations at week 12 with no new safety concerns".
Voydeya has so far been granted Breakthrough Therapy designation by the US FDA, "PRIority MEdicines" status by the European Medicines Agency, as well as Orphan Drug designation in the US, EU and Japan.
Separately, AstraZeneca announced that its biologics licence application for datopotamab deruxtecan had also been accepted by the FDA.
Datopotamab, discovered by Daiichi Sankyo Co Ltd and jointly developed alongside AstraZeneca, is used to treat HR-positive, HER2-negative breast cancer, the most common subtype of the disease.
Susan Galbraith, vice president of oncology research and development at AstraZeneca, said: "If approved, datopotamab deruxtecan has the potential to provide these patients an efficacious and better tolerated alternative to conventional chemotherapy."
Ken Takeshita, head of R&D at Daiichi, added: "The FDA's acceptance of the BLA brings us closer to providing patients with previously treated HR-positive, HER2-negative breast cancer an alternative option to conventional chemotherapy earlier in the metastatic setting. Following our recently accepted application for advanced nonsquamous non-small cell lung cancer in the US, along with additional regulatory reviews underway in China, the EU, Japan and other regions, we are working swiftly to bring datopotamab deruxtecan as a potential new treatment option to patients around the world."
In early March, the pair received two marketing authorisation approvals from the European Medicines Agency for datopotamab to treat non-small cell lung cancer and adults with metastatic hormone receptor positive or HER2-negative breast cancer considered unsuitable for endocrine therapy.
An additional biologics licence is under FDA review for the use of datopotamab to treat non-small cell lung cancer.
Shares in AstraZeneca were down 1.6% at 10,432.00 pence each in London on Wednesday morning.
Shares in Daiichi closed up 0.9% at JPY4,676.00 each in Tokyo on Wednesday.
By Hugh Cameron, Alliance News reporter
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