The World Health Organization (WHO) has added “lifesaving” interleukin-6 receptor blockers to its list of treatments for COVID-19 – only the second drugs to be recommended as effective against the disease – as the pandemic continues to accelerate across the world.
The WHO said the medicines worked particularly well when used alongside corticosteroids, which were recommended by the WHO in September 2020.
“These drugs offer hope for patients and families who are suffering from the devastating impact of severe and critical COVID-19,” WHO Director-General Tedros Adhanom Ghebreyesus said in a statement.
Patients with severe cases of COVID-19 often suffer from an overreaction of the immune system and the interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress the overreaction.
The WHO said the trials showed that in severely ill patients, administering the drugs resulted in 15 fewer deaths per 1,000 patients. For the critically ill the use of interleukin-6 meant as many as 28 fewer deaths for every 1,000 patients. The medicines also meant the chance of severe and critically ill patients being put on a ventilator was reduced by 28 percent, compared with standard care.
The recommendation comes as countries around the world including South Africa, Indonesia and Bangladesh battle devastating new waves of the virus fuelled by the Delta variant that first emerged in India. An effort is already under way at the World Trade Organization to remove patent protections on COVID-19 vaccines to improve access for poorer countries, and there are calls to lift intellectual property barriers on drugs crucial to the effective treatment of severe coronavirus.
Tocilizumab belongs to a class of drugs called monoclonal antibodies (mAbs) that are used in the treatment of various diseases including arthritis and cancer, and is manufactured by the Swiss pharmaceutical giant, Roche. It sells the drug under the brand name Actemra.
Following the WHO recommendation, Doctors without Borders (known by its French initials, MSF) urged Roche to lower the price of the drug to make it affordable and accessible, and share the know-how, master cell lines and technology to allow other manufacturers across the world to make the medicine, too.
“This drug could become essential for treating people with critical and severe cases of COVID-19 and reduce the need for ventilators and medical oxygen which are scarce resources in many places,” Julien Potet, neglected tropical diseases policy adviser at MSF’s Access Campaign, said in a statement. “Roche must stop following a business-as-usual approach and take urgent steps to make this drug accessible and affordable for everyone who needs it by reducing the price and transferring the technology, know-how and cell lines to other manufacturers. Too many lives are at stake.”
Most of the existing mAbs are expensive, putting them out of reach for low- and middle-income countries.
MSF said while tocilizumab has been on the market since 2009, the price remained very high in most countries – from $410 in Australia to $646 in India and $3,625 in the United States for a 600mg dose for COVID-19. The cost to manufacture tocilizumab is estimated to be as low as $40 per dose of 400mg, it added.
Sarilumab, the second mAb recommended by WHO, is made by US pharmaceutical company Regeneron and French drugmaker Sanofi, which market the product under the brand name Kevzara. Regeneron has applied for and been granted patents on sarilumab and its formulation in at least 50 low- and middle-income countries, according to MSF.
The WHO also called on manufacturers to reduce the price of the drugs, accept transparent, non-exclusive licensing agreements or waive exclusivity rights.
“IL-6 receptor blockers remain inaccessible and unaffordable for the majority of the world,” Ghebreyesus said.
“The inequitable distribution of vaccines means that people in low- and middle-income countries are most susceptible to severe forms of COVID-19. So, the greatest need for these drugs is in countries that currently have the least access. We must urgently change this.”
The recommendation follows the analysis of data from more than 10,000 patients involved in 27 clinical trials.