Shares in pharmaceutical giant AstraZeneca (AZN) rallied 1% to £85.77 on Monday after the company said its chronic kidney disease drug had been recommended for approval in the EU.
The European Medicines Agency based its opinion on results from the DAPA-CKD phase three trial which showed that the company’s kidney drug Forxiga, when used on top of standard care treatment, reduced the risk of the composite of worsening of renal function, end-stage kidney disease and cardiovascular or renal death.
Forxiga also ‘significantly’ reduced the risk of death from any cause compared to the placebo, while safety and tolerability were said to be consistent with the well-established safety profile of the medicine.
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Chronic kidney disease is a progressive condition that affects around 47 million people across the EU and nearly 840 million worldwide according to studies.
AstraZeneca’s executive vice president Mene Pangalos said: ‘This positive CHMP opinion underscores Forxiga's potential to transform the future care of chronic kidney disease and brings us one step closer to providing a much-needed new treatment option to millions of patients in the EU.’
Astra also announced that a trial evaluating the safety and tolerability of its RSV (respiratory syncytial virus) drug Nirsevimab demonstrated favourable results.
Nirsevimab is being developed as a passive immunisation against RSV for all infants and acts as a long-acting antibody. The drug uses proprietary technology being developed by Astra and its French partner Sanofi which has the potential to provide immunity directly to all infants for the entire season with a single dose.
Pangalos commented: ‘These results contribute to the body of evidence demonstrating nirsevimab's potential to protect all infants against respiratory syncytial virus with one dose. We look forward to sharing the results with regulators.’
