EU regulators begin fast review of dexamethasone for COVID-19

European regulators have begun a speedy review of dexamethasone as a treatment for adults hospitalised with COVID-19, a potentially cheaper option to aid recovery than Gilead’s Veklury.

Dexamethasone is a generic steroid that has been repurposed as a treatment for COVID-19, where it has been shown to alleviate the severe respiratory complications seen with the disease.

The hope is that dexamethasone will be more affordable than Veklury (remdesivir), which costs around $3,120 for a course.

The filing comes for the formulation known as Dexamethasone Taw which comes from Taw Pharma, a little-known UK pharma with no public website that is based in Devon, according to records at Companies House.

In July, Gilead’s Veklury (remdesivir) became the first drug cleared by EU regulators to treat symptoms in patients hospitalised with COVID-19.

That review lasted around three months from filing to approval by the European Commission, compared with standard timeframes that can last more than a year.

For dexamethasone, European regulators from the CHMP scientific committee will review findings from the UK’s RECOVERY trial, which found there were fewer deaths in patients hospitalised with COVID-19 treated with the drug.

In patients on invasive mechanical ventilation, 29% of those treated with dexamethasone died within 28 days of starting dexamethasone treatment compared with 41% of patients receiving usual care, a relative reduction of about 35%.

In patients receiving oxygen without mechanical ventilation, the figures were 23% with dexamethasone and 26% with usual care. No reductions in death occurred in patients who were not receiving oxygen therapy or mechanical ventilation.

Before receiving this application, the CHMP had started reviewing the results of the RECOVERY trial in order to provide an opinion on the use of dexamethasone medicines for COVID-19. The outcome of this review will be considered in the evaluation of Dexamethasone Taw.

Should the available data show that the benefits of Dexamethasone Taw outweigh its risks in the treatment of hospitalised adults with COVID‑19, EMA will issue a positive recommendation on the medicine’s new use in patients with COVID-19. The agency will then liaise with the European Commission to fast-track the authorisation.

The drug is being developed as a “hybrid medicine” – it is similar to a reference drug known as Fortecortin Inject containing the same active substance but differs in other respects such as strength or pharmaceutical form.

If authorised Dexamethasone Taw will be available as an injectable drug and will be used to treat the same conditions with the addition of COVID-19.

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