A recent updation of the World Health Organisation’s patient care guidelines has given Roche’s Tocilizumab a shot in the arm.

The WHO has included interleukin-6 receptor blockers, a class of medicines that are lifesaving in patients who are severely or critically ill with Covid-19, especially when administered alongside corticosteroids.

Significantly, these are the first drugs found to be effective against Covid-19 since corticosteroids (dexamethasone) were recommended by the WHO in September 2020. And to increase access and affordability to these life-saving products, the WHO also called on manufacturers to reduce prices and make supplies available to low- and middle-income countries, especially where Covid-19 was surging. Roche’s Tocilizumab is supplied in India through Cipla.

In a statement, the WHO said: “Patients severely or critically ill with Covid-19 often suffer from an overreaction of the immune system, which can be very harmful to the patient’s health. Interleukin-6 blocking drugs – tocilizumab and sarilumab – act to suppress this overreaction.” The updation followed findings from meta-analysis initiated by WHO, where data from over 10 000 patients enrolled in 27 clinical trials was considered.

‘Waive exclusivity right’

The WHO went on to encourage companies “to agree to transparent, non-exclusive voluntary licensing agreements using the C-TAP platform and the Medicines Patent Pool, or to waive exclusivity rights”.

Further, it added, that it had launched an expression of interest for prequalification of manufacturers of interleukin-6 receptor blockers. Prequalification of innovator and biosimilar products aims to expand the availability of quality-assured products and to increase access through market competition and reduce prices to meet urgent public health needs, it explained.

Echoing the WHO’s statement, Médecins Sans Frontières/Doctors Without Borders (MSF) also called on the Swiss pharmaceutical corporation Roche, the world’s sole producer of the drug, “to lower the price of the drug to make it affordable and accessible for everyone who needs it, everywhere”.

In a statement, the humanitarian organisation said: “Roche must end its monopoly and urgently share the know-how, master cell lines and technology needed to produce this drug with other manufacturers across the world to ensure supply and improved access.”

Tocilizumab belongs to the class of drugs called monoclonal antibodies (mAbs) that are used in the treatment of various diseases, including cancer. “However, most of the existing mAbs have been priced extremely high, and are hence virtually impossible to access in low- and middle-income countries,” MSF said.

“Over the last few months, we have helplessly witnessed people in South Asia scrambling to get hold of tocilizumab for patients with severe forms of Covid-19,” said Leena Menghaney, Global IP advisor for MSF Access Campaign. “Manufacturers based in low- and middle-income countries urgently need to register and scale up production to increase the global supply. With more than 3.9 million lives already lost to Covid-19, the world cannot wait any longer for access to treatments that can help in increasing the chances of survival,”she added.

The other mAb recommended by WHO, sarilumab, is also under wide patent protection globally, MSF said. “Regeneron has applied for and been granted patents on sarilumab and its formulation in at least 50 low- and middle-income countries, raising immediate challenges of ensuring uninterrupted production and supply by diverse producers in these countries.”

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