hameln pharma ltd’s dexamethasone is now licensed for use in COVID-19. The updated Summary of Product Characteristics (SmPC) reflects the findings of the RECOVERY trial (Randomised Evaluation of COVid-19 thERapY)1, that showed the use of dexamethasone reduced the risk of dying by one-third in ventilated patients and by one fifth in non-ventilated patients receiving oxygen only.
Steve Watkin, Managing Director of hameln in the UK commented, “hameln have been supplying dexamethasone injections to the NHS for almost 10 years. We are delighted that our product was of use in the RECOVERY trial and how dexamethasone – a widely available and well-established drug – was shown to reduce mortality when used appropriately in COVID-19 patients.
“We are proud that hameln’s dexamethasone has been approved by the UK MHRA for the treatment of COVID-19 patients and in doing so provides clarity for the UK’s medical professionals regarding the appropriate use of dexamethasone in those patients. This approval is a result of great work at pace by both the MHRA and our own Medical Affairs Team. Having the first dexamethasone injection to be formally approved for the treatment of COVID-19 patients is great news”
Full prescribing information is available here