Tocilizumab and Covid-19 testing: Roche in the limelight

Pharmaceutical giant Roche was recently in the news for all the right reasons. First was the fact that its monoclonal antibody tocilizumab (Actemra®) is currently being tested in China for the treatment of COVID-19. The second piece of positive news comes from its diagnostic division, where the Roche SARS-CoV-2 test was approved by the US FDA. 

China included tocilizumab in its National Health Commission treatment guidelines for COVID-19, dated March 3. [Available at www.nhc.gov.cn/yzygj/s7653p/202003/46c9294a7dfe4cef80dc7f5912eb1989.shtml Accessed on 16 March] The drug was initially indicated for treatment of rheumatoid arthritis, and more recently, the cytokine release syndrome associated with chimeric antigen receptor (CAR) T-cell treatment.

Roche donated 10,000 vials of tocilizumab to China after Chinese doctors revealed during a press conference that promising improvements were seen in some critically ill patients treated with existing medications, including those used in arthritis. One of these was tocilizumab.

The University of Science and Technology of China in Anhui wasted no time in initiating a clinical trial* to recruit 188 patients, half of which will be randomized to tocilizumab plus conventional therapy and the remaining half to conventional therapy alone.

MIMS Doctor reached out to Roche to gain more insight into the use of tocilizumab in the treatment of COVID-19. A Roche Medical Information correspondent mentioned that it was important to note that there is no published clinical evidence regarding the safety or efficacy of tocilizumab in the treatment of COVID-19.

She added: “Roche is aware that the current situation is a major burden for patients and their beloved ones. While there are currently no medicines to treat human coronaviruses, Roche remains committed to the WHO and other relevant stakeholders as necessary, to provide expertise and advice on coronavirus. Roche is also committed to contributing to the containment of coronavirus spread through its diagnostic solutions. The information provided may include the use of the product outside the product’s license. Roche is providing this information in response to your enquiry. We cannot recommend the use of our products for any indication, dosage, or route of administration not covered in the product’s license.”

Dr Charles Li, Medical and Regulatory Director of Roche Malaysia, echoed the sentiments and reiterated that no health authority apart from China has approved tocilizumab for use in treatment of COVID-19. He said: “Given the lack of approved treatment options, we understand that there may be off-label use of products approved for other uses.”

He added: “Roche respects the physician’s clinical decisions,  and we believe that when a physician chooses to prescribe a medicine, approved or otherwise, they should do so because they believe it is the most appropriate medicine for an individual patient, taking into account relevant national laws and regulations.”

When doctors prescribe a medicine for off-label use, they do so with the knowledge that the product has not gone through the stringent regulatory process for the specific disease in question, so there is a greater degree of uncertainty associated with its use.

On the possibility of Roche donating supplies of tocilizumab for use in the government setting, Li said all such requests are handled exclusively by the local General Manager through direct contact with the local authorities and aid organizations, and based on the related needs.

COVID-19 testing speeds up
Fresh on the heels of the news on tocilizumab’s use in COVID-19 patients is the announcement that Roche has now launched a new test for the novel coronavirus which is “10 times faster” than existing tests. The US FDA granted emergency use authorization to the test due to the unique and pressing nature of the coronavirus pandemic.

The tests run on Roche’s cobas® 6800 and 8800, both of which are available in Malaysia. The 8800 system can test over 4,000 samples a day while the 6800 system can test over 1,400 samples a day. Each run will take about 4 hours. MIMS Doctor has reached out to Roche to see how soon the tests will be made available in Malaysia.

A hallmark of serious disease in those with COVID-19, drastically elevated interleukin 6 (IL-6) or otherwise famously known as the “cytokine storm”, is thought to be a target for treatment. This was suggested in a recent paper which saw the link between RNAaemia and extremely elevated IL-6 levels in critically ill COVID-19 patients. [Available at https://doi.org/10.1101/2020.02.29.20029520 ]

Being an IL-6 receptor antagonist, tocilizumab blocks IL-6 receptors, and suppresses the immune system and subsequent inflammatory response, thus possibly attenuating the serious symptoms of COVID-19.  

*Trial registration number ChiCTR2000029765: A multicenter, randomized controlled trial for the efficacy and safety of tocilizumab in the treatment of new coronavirus pneumonia (COVID-19).