By Pushkala Aripaka and Yadarisa Shabong
(Reuters) – Europe’s healthcare regulator has endorsed using dexamethasone to treat COVID-19 patients with breathing difficulties, paving the way for the steroid to become the region’s second approved treatment for the respiratory illness.
The European Medicines Agency (EMA) said on Friday the drug could be an option to treat adults and adolescents needing oxygen therapy or mechanical ventilation, after concluding its review of results from a trial by British scientists.
The study, dubbed RECOVERY, by researchers at the University of Oxford, showed in June that dexamethasone reduced death rates by about a third in severely ill, hospitalized COVID-19 patients. The drug has since been approved in Japan as a COVID-19 treatment.
The decades old drug is cheap and widely available, commonly used against a range of inflammatory conditions. Companies can now apply for a licence to their national regulators or the EMA for an expanded use of the drug, the watchdog said.
It said the recommended dose in adults and adolescents, from the age of 12 years and weighing at least 40 kilograms, was 6 milligrams once a day for up to 10 days.
The EMA was already evaluating Taw Pharma’s branded steroidal version of the medicine for the illness caused by the novel coronavirus after it received an application from the drug developer earlier this month.
Britain’s Hikma Pharmaceuticals said in June it had seen demand increase and was prepared to scale up production following the RECOVERY results. The company did not immediately respond to a request for comment on the EMA endorsement.
While approvals are up to the European Commission, it typically follows the EMA’s recommendations for its decisions.
Gilead’s antiviral drug, remdesivir, was the first to be approved for COVID-19 by Europe in July, about a month after the EMA endorsed the drug. It is branded as Veklury in the region.
Reporting by Yadarisa Shabong and Pushkala Aripaka in Bengaluru; Editing by Shinjini Ganguli and Mark Potter.