EMA Endorses Use Of Dexamethasone In COVID-19
The Move Should Speed Up EU National Approvals
Executive Summary
Companies marketing dexamethasone in Europe have been told they can use a CHMP endorsement to request the addition of COVID-19 to their product license.
The European Medicines Agency’s drug evaluation committee, the CHMP, has given an opinion endorsing the use of dexamethasone as a treatment option for hospitalized COVID-19 patients who require oxygen therapy.
Companies already marketing the corticosteroid have been told by the agency that they can request this new use to be added to their product’s license by submitting a variation application to national medicines agencies or to the EMA. The CHMP’s endorsement should help to speed up the evaluation of such applications.
The move follows a review by the CHMP of the results from the dexamethasone arm of the UK Recovery trial, which showed that the product reduced mortality in patients requiring oxygen therapy (including supplementary oxygen and mechanical ventilation).
“The CHMP opinion can also speed up the evaluation of individual applications in different national competent authorities" – EMA
The review was carried out under Article 5(3) of Regulation 726/2004, whereby the CHMP can give an opinion on any scientific matter concerning the evaluation of medicines for human use. The EMA explained that while such opinions are not legally binding, they can be taken into consideration during the evaluation of applications for variations or initial marketing authorization applications.
“The CHMP opinion can also speed up the evaluation of individual applications in different national competent authorities, and provides a basis for harmonization of the product information,” it told the Pink Sheet.
This latest opinion can also be taken into account as the CHMP evaluates the centralized marketing authorization application (MAA) for a new dexamethasone product for COVID-19 that was submitted by UK consultancy firm Taw Pharma, the agency added. The MAA was filed on behalf of an unnamed pharmaceutical company. (Also see "COVID-19: Mystery Company Eyes EU Approval For Dexamethasone Taw" - Pink Sheet, 2 Sep, 2020.)
Asked whether the endorsement could be used by member states to facilitate access to dexamethasone for COVID-19 patients before this use has been formally added to the license, the agency said it would need to check with its experts.
Some steps have already been taken to make dexamethasone available for use in COVID-19. Announcing the Recovery results in June, the UK said the product should be used in hospitalized patients and also placed it on the list of products that cannot be exported.
The Review
The CHMP review of dexamethasone began in July following preliminary discussions with the COVID-19 EMA pandemic task force, which brings together experts from across the EU regulatory network.
“Based on the review of available data, EMA is endorsing the use of dexamethasone in adults and adolescents (from 12 years of age and weighing at least 40 kg) who require supplemental oxygen therapy,” the agency declared.
“Dexamethasone can be taken by mouth or given as an injection or infusion (drip) into a vein. In all cases, the recommended dose in adults and adolescents is 6 milligrams once a day for up to 10 days.”
The EMA noted that the Recovery study showed that 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, with a relative reduction of about 35%.
In patients receiving oxygen without mechanical ventilation, the figures were 23% with dexamethasone and 26% with usual care, with a relative reduction of about 20%. No reduction in the risk of death occurred in patients who were not receiving oxygen therapy or mechanical ventilation.
These results were supported by additional published data, including a meta-analysis conducted by the World Health Organization that looked at data from seven clinical studies investigating the use of corticosteroids for the treatment of patients with COVID-19, the agency added.