GlaxoSmithKline and rival AstraZeneca have both received positive updates from the US Food and Drug Administration for two drugs.
(Picture: PA)GlaxoSmithKline and AstraZeneca have secured victories with the US regulator in relation to treatments that could become blockbuster drugs for the firms.
Glaxo’s Daprodustat, which is used for the treatment of anaemia in chronic kidney disease patient, has had its application for approval accepted by the Food and Drug Administration (FDA) in the US after its successful phase III clinical trial.
This triumph for the drug, which is already available in Japan, comes after the European Medicines Agency accepted its application for approval last month.
Daprodustat sits within Glaxo’s new and speciality drug division, whose nearly £10 billion in sales in 2021 made it the best performing part of its pharmaceuticals business last year.
At the same time, AstraZeneca’s Enhertu, which it has developed with Japan’s Daiichi Sankyo, has been granted ‘Priority Review’ status following a successful clinical trial.
Enhertu is used as a treatment for adults with unresectable or metastatic non-small cell lung cancer, whose tumours have a HER2 mutation and who have received a prior but unsuccessful therapy.
According to AstraZeneca’s latest results, Enhertu registered sales of $214 million in 2021 but if this latest development leads to full approval, the firm will hope it can reach the much-vaunted ‘blockbuster’ status - $1 billion in annual sales.
Lung cancer is the second most common form of cancer globally, with more than 2 million new cases diagnosed in 2020, according to Astra Zeneca. It added that for patients with the type of lung cancer that Enhertu helps to treat, that prognosis is “particularly poor”, with only 8 per cent of patients living beyond five years after diagnosis.
Susan Galbraith, executive vice president, oncology R&D, at AstraZeneca, said: “If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options.”
For GSK, its trials for Daprodustat, which covered more than 8,000 patients over more than four years, showed positive results in patients who were on dialysis as well as those that were not.
The company said anaemia was “often poorly diagnosed and undertreated” in chronic kidney disease, which affects 700 million people worldwide. An estimated 1 in 7 of those have anaemia.
