WHO prequalifies Roche’s arthritis drug for severe COVID cases

SWITZERLAND – In an effort to increase access to the costly drug, the World Health Organization announced that it has prequalified the arthritis treatment tocilizumab for use in patients hospitalized with severe COVID-19, taking the total tally of such treatments to six.

The monoclonal antibody, which is used in anti-inflammatory drugs manufactured by the Swiss pharmaceutical giant Roche, has been shown to reduce the risk of death as well as hospitalization time in certain patients suffering from severe COVID.

WHO, like the US and the EU, has already recommended it for the treatment of severe COVID in hospital settings.

However, it is still in short supply and very expensive—a single dose reportedly costs up to US$600 in low-income countries, according to WHO, though its prequalification should help make it more accessible.

The UN health agency announced the addition of three different monoclonal antibody compositions to its list of prequalified treatments for the pandemic disease, in an effort to spur the production of more affordable generic versions.

The listings should pave the way for more companies coming forward to seek WHO prequalification, thereby increasing the number of quality-assured products and creating competition leading to potentially lower prices,” WHO said in a statement.

The prequalification of these products will also facilitate low- and middle-income countries’ authorization of them as COVID treatments,” it said.

According to WHO, the prequalification process is primarily intended to ensure the quality, safety, and efficacy of medical products procured for developing countries.

Prior prequalifications

Prior to tocilizumab, the WHO prequalified three different formulations of the steroid dexamethasone for the treatment of COVID, as well as Gilead’s antiviral remdesivir, though that prequalification has since been suspended.

Tocilizumab was previously approved in approximately 120 countries, primarily for the treatment of arthritis.

During the pandemic, however, it has been shown to suppress a dangerous “cytokine storm”—the immune system’s overreaction to the coronavirus.

WHO pointed out that the patent for tocilizumab had expired for most uses.

This, it said, “means there should be no intellectual property barriers,” although it warned there was “low global availability for quality-assured biosimilars of the product“.

WHO said it is currently discussing with Roche how to lower prices and improve access in low- and middle-income countries.

But it stressed that while the prequalification was specifically for Roche products, “many generic companies are already producing tocilizumab, some of which have also applied for prequalification“.

If they are found to comply with WHO standard… they can enter international markets.”

In a sense, prequalification is also indirectly promoting quality local production, and ultimately greater supply and more competitive prices.”

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