Calls for key COVID drug to be made available outside US

Bebtelovimab is "particularly good at targeting the mutated spike protein of the BA.4 and BA.5 Omicron subvariants."

Researchers have called for an experimental COVID-19 treatment, which has shown early indications of being more effective against dominant Omicron subvariants, to be made available outside the United States.

Numerous monoclonal antibody treatments have helped blunt the worst of the disease for patients since the start of the pandemic, but their effectiveness has been weakened as the virus mutates.

However, one such anti-viral treatment, bebtelovimab, is "particularly good at targeting the mutated spike protein of the BA.4 and BA.5 Omicron subvariants," said Antoine Flahault, director of the Institute of Global Health at the University of Geneva.

But as BA.4 and BA.5 run rampant in many countries, the drug made by American pharmaceutical firm Eli Lilly has so far only been made available in the US.

Bebtelovimab has not yet been officially approved in the US, but received "emergency use authorization" earlier this year following positive results from a trial involving patients with mild to moderate COVID symptoms.

The US government ordered 600,000 doses in February, then another 150,000 doses late last month.

But as more evidence emerges of how weak other monoclonal antibodies are against BA.5 and BA.5, some are calling for the rest of the world to get access to the drug.

Five Europe-based medical researchers wrote a letter published in the Lancet Infectious Disease journal this week saying that among monoclonal antibodies, bebtelovimab "stands out" against the dominant Omicron subvariants.

"Bebtelovimab would be an important anti-viral globally," the researchers wrote, adding that it "should be made available outside the US for patients worldwide."

On Wednesday, France's COVID Scientific Council asked the French government "to do everything possible to ensure that bebtelovimab, the only monoclonal antibody treatment currently active against BA.5, is available as soon as possible in France."

'This drug can save lives'

Eli Lilly said that it "maintains permanent and open communication with health authorities around the world, in order to understand the local need for this antibody, bebtelovimab, which remains experimental for the time being."

The company added that "in Europe, in view of the available data which is considered preliminary," it did not currently plan to make the drug available for trials or apply for authorisation to market it on the continent.

Eli Lilly said bebtelovimab had not been the subject of a European Medicines Agency (EMA) procedure for emergency use, "as was the case for the previous neutralising antibodies against COVID-19."

Given the stakes, some urged quick action.

"This drug can save lives," Flahault said.

"We should consider making it a global public good in order to make it available to very vulnerable patients who could benefit from it around the world."

He said such treatments were particularly important for COVID patients who were at a higher risk of severe symptoms, or whose immune systems had been comprised.

"This is the drug that retains the best efficacy against BA.5," tweeted Renaloo, a French association of kidney disease patients.

"What are our European health authorities waiting for... to guarantee access to immunocompromised patients who need it?"

The calls for wider access come during a pandemic which has consistently seen the wealthy countries where new treatments and vaccines have been developed save the critical first doses for themselves.

The vast gap in access between higher and lower income countries has spurred numerous nations to call for intellectual property rights to be temporarily lifted on COVID vaccines and treatments, allowing them to boost local production.

On Tuesday IFPMA, which represents global pharmaceutical firms, called on wealthy countries to work toward a more equitable distribution for vaccines and treatments in the case of a potential future pandemic.

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