GSK and AstraZeneca secured victory with US drug regulator

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laxoSmithKline and AstraZeneca secured victory with USA regulator regarding treatments that could become blockbusters for companies.

Glaxo preproduct, used to treat anemia in patients with chronic kidney disease, has been approved for approval Food and Drug Administration (FDA) in the United States after a successful phase III clinical trial.

This triumph of the drug, which is already available in Japan, came after the European Medicines Agency accepted its application for approval last month.

Daprodustat is in Glaxo’s division for new and specialty drugs, whose sales of nearly £ 10 billion in 2021 made it the most efficient part of its pharmaceutical business last year.

At the same time, Enhertu from AstraZeneca, which she developed in collaboration with the Japanese Daiichi Sankyo, received the status of “priority review” after a successful clinical trial.

Engertu is used as a treatment for adults with inoperable or metastatic non-small cells lung cancertumors that have the HER2 mutation and that have received prior but unsuccessful therapy.

According to the latest results from AstraZeneca, in 2021 Enhertu’s sales amounted to 214 million dollars, but if this latest development leads to full approval, the company will hope that it will be able to achieve high status as a “blockbuster” – $ 1 billion in annual sales.

Lung cancer is the second most common form of cancer in the world: in 2020, more than 2 million new cases were diagnosed, according to Astra Zeneca. He added that for patients with the type of lung cancer that helps treat Engert, the prognosis is “particularly poor,” and only 8 percent of patients live more than five years after diagnosis.

Susan Galbright, executive vice president of oncology research and development at AstraZeneca, said: “If approved, Enhertu could become the new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic minor metastases. cellular lung cancer that does not currently have targeted treatment options. ”

For GSK, its trials of the product, which covered more than 8,000 patients over four years, showed positive results in patients on dialysis as well as those who were not.

The company said anemia is “often poorly diagnosed and untreatable” in chronic kidney disease, which affects 700 million people worldwide. It is estimated that every 7 of them have anemia.

GSK and AstraZeneca secured victory with US drug regulator

Source link GSK and AstraZeneca secured victory with US drug regulator

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