At the end of last month, the European Commission announced a first group of five Covid-19 therapeutics it will prioritise for review, authorisation, and expedited production across the bloc over the next several months. The grouping includes four monoclonal antibody treatments – Eli Lilly’s cocktail of bamlanivimab and etesevimab, Regeneron’s combination of casirivimab and imdevimab, Celltrion’s regdanvimab, and GlaxoSmithKline’s sotrovimab – and one immunosuppressant, Eli Lilly’s baricitinib.
In making the announcement, Commissioner for Health Stella Kyriakides pointed out the EU would be taking additional therapeutics into consideration as part of the scheme, with the ultimate objective of having at least three treatments fully authorised and readily available as part of a “broad portfolio of therapeutics to tread Covid-19” by the end of this year. As Kyriakides made clear: “whilst vaccination is progressing at increasing speed, the virus will not disappear and patients will need safe and effective treatments to reduce the burden of COVID-19.”
In the days since, new findings surrounding the Delta variant have made the Cypriot Commissioner’s case for her. In Israel, which has effectively functioned as a real-world laboratory for testing the effectiveness of the Pfizer/BioNTech mRNA vaccine, Covid-19 infections this week jumped up 50% between Sunday and Monday, with vaccinated individuals representing over 40% of those infected and the new variant accounting for over 90% of new Covid-19 cases in the country. Per Israeli Health Ministry data, the Pfizer/BioNTech jab is only 64% effective in stopping infection by the Delta variant, although findings from the UK have found a less severe drop in efficacy.
Even if vaccinated individuals in both countries still enjoy protection from the types of severe symptoms that require hospitalisation, the emergence of the Delta variant has made unvaccinated people even more vulnerable than they already were. It has also added new urgency to the EU’s therapeutics strategy, especially given European doctors and hospitals still need more treatment options for patients in critical care.
Leukine leads slate of existing treatments
In addition to the five candidate therapeutics already singled out by the Commission, a number of other new and existing treatment options have already demonstrated their potential to save lives over the course of studies conducted over the past year and a half. Soon after the start of the first wave last March, for example, University Hospital Ghent in Belgium kicked off a major trial across five Belgian hospitals to determine whether the drug sargramostim (marketed by US-based Partner Therapeutics as Leukine), long used by bone marrow transplant recipients and leukaemia patients undergoing chemotherapy to regenerate white blood cells, could also help improve lung function among severely ill Covid-19 patients.
When the University Hospital Ghent published the results of that study earlier this year, its findings proved highly promising. Leukine substantially improved oxygenation among Covid-19 patients suffering from hypoxemia (low blood oxygen levels), increasing oxygenation rates by at least a third in the majority of patients who received an inhaled version of the drug – all while simultaneously stimulating immune cells to combat the viral infection. Subsequent findings in the United States have reinforced University Hospital Ghent’s findings, with a trial covering 11 American hospitals and backed by the US Department of Defence illustrating a substantial increase in oxygenation levels among patients who received the drug.
Given that respiratory failure is one of the primary dangers facing Covid-19 patients in critical care, identifying effective remedies to improve lung function and oxygenation levels are an obvious priority for the Commission’s therapeutics strategy. The efficacy of existing drugs like sargramostim makes the European Medicines Agency (EMA)’s job of determining the safety of prospective Covid-19 treatments all that much easier, as these therapeutics have already been reviewed and approved by major international regulators such as the Food and Drug Administration (FDA) in the United States.
New, Covid-specific remedies
Alongside existing drugs such as sargramostim, which can address many of the most dangerous symptoms of Covid-19 infections, the EU, US, and UK are all working on antiviral treatments that can tackle the virus itself. Thus far, the EMA has only conditionally approved one antiviral drug – remdesivir, produced by the American pharmaceutical company Gilead – while rejecting candidates such as ivermectin. But while European medical authorities have historically been reticent to embrace antiviral treatments as an effective tool against influenza and other viral epidemics, the sheer destructive force of Covid-19 has forced a rethink to their usual thinking around the trade-off between benefits and potential side effects.
The development of antivirals designed specifically to combat the SARS-CoV-2 virus could help them make that shift. Pfizer, for example, is looking to build upon the branding success of its mRNA vaccine with a protease inhibitor, PF-07321332, which can be administered in pill form and which the company hopes will cut short recovery times after Covid-19 patients have been infected – but before they wind up in the hospital. Pfizer’s antiviral treatment is currently undergoing Phase 1 trials in the United States and at the company’s facilities in Belgium, and the spate of media coverage surrounding the experimental molecule shows, successful trials could transform the shape of the pandemic by the time the EU’s therapeutics strategy is scheduled to complete its work.
If it proves effective, this type of easily administered, at-home treatment could tackle Covid-19 infections in much the same way Tamiflu works against influenza. Even if Pfizer’s antiviral candidate fails to live up to expectations, however, the speed with which the EU, UK, and US have hit upon effective treatment regimens and inoculations offers room for optimism that a Delta-driven third wave will not be nearly as lethal as the two which proceeded it.