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Fresh guidance from the World Health Organization recommending the use of dexamethasone and hydrocortisone to treat patients with severe and critical COVID-19 provides the latest demonstration of the potential held by common and low-cost generics in the fight against the coronavirus pandemic.

In updated clinical care guidance published on 2 September, the WHO recommended the use of systemic corticosteroids for the treatment of patients with severe and critical COVID-19, while at the same time suggesting “not to use corticosteroids in the treatment of patients with non-severe COVID-19, as the treatment brought no benefits, and could even prove harmful.”

A “strong recommendation” by the international panel of content experts, patients, clinicians and methodologists recommended “systemic (i.e. intravenous or oral) corticosteroid therapy (e.g. 6mg of dexamethasone orally or intravenously daily or 50mg of hydrocortisone intravenously every eight hours” for patients with severe and critical COVID-19.

The panel based its recommendations on two meta-analyses pooling data from eight randomized trials of systemic corticosteroids for COVID-19 and were also informed by two other previously published meta-analyses on the safety of systemic corticosteroids in distinct but relevant patient populations.

“The resulting evidence summary suggested that systemic corticosteroids probably reduce 28-day mortality in patients with critical COVID-19 and also in those with severe disease,” the WHO guidance notes, based on “moderate certainty evidence.” In contrast, “systemic corticosteroids may increase the risk of death when administered to patients with non-severe COVID-19,” the guidance suggests based on “low certainty evidence.”

“In addition, systemic corticosteroids probably reduce the need for invasive mechanical ventilation,” the guidance observes, with “moderate certainty of evidence.” It emphasizes that “harms, in the context of the mortality reduction in severe disease, are minor.”

Available Worldwide At Low Cost

The WHO pointed out that “corticosteroids are listed in the WHO model list of essential medicines [and are] readily available globally at a low cost.” It therefore encouraged countries to “maintain sufficient stocks of corticosteroids to treat COVID-19 and the other disease for which they are effective, while not maintaining excessive stocks which could deny other countries access.”

“Work on this guidance began on 22 June when the RECOVERY trial published a preliminary report on the impact of corticosteroids,” the WHO noted. Off-patent industry representatives had at the time labelled the positive trial results for dexamethasone as encouraging, but at the same time had cautioned that careful national procurement planning would be key to manage demand for medicines that become high-profile treatment options to address the coronavirus pandemic.  (Also see "Dexamethasone Shows Potential Of Repurposed Generics Against COVID-19" - Generics Bulletin, 18 Jun, 2020.)

To supplement the RECOVERY results, the WHO said it had partnered with investigators of seven trials on corticosteroids to conduct a meta-analysis of these trials, “in order to rapidly provide additional evidence to build on RECOVERY data and inform guidance development.”

Accord’s executive vice-president for Europe, the Middle East and North Africa, James Burt, recently told Generics Bulletin that the generics industry had been proactive in conducting science reviews to help find generic drugs with the potential to treat COVID-19 effectively.

“As different experimental medicines get into trial, we’re keeping an eye on that, to make sure that – should there be a need – we can prioritize other medicines,” Burt said. “We want to make sure that if there is a likely candidate, we have secured the supply.”  (Also see "European Industry Played Key Role In Mitigating COVID-19" - Generics Bulletin, 30 Jul, 2020.)

Dexamethasone could potentially soon be authorized for use in the EU for treating hospitalized adult patients with COVID-19, after the European Medicines Agency began evaluating a marketing application for this purpose.  (Also see "COVID-19: Mystery Company Eyes EU Approval For Dexamethasone Taw" - Pink Sheet, 2 Sep, 2020.)


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