China has approved Actemra to treat COVID-19 patients. Actemra, Roshe’s anti-inflammatory drug, has received the green light in China as a new way to tackle severe lung damage in patients with COVID-19.
Actemra to treat COVID-19 patients
Actemra is approved to be used for coronavirus (COVID-19) patients with deteriorating lung function. The rapid approval ensures that Actemra (tocilizumab) – an interleukin-6 inhibitor – can be used to treat new coronavirus infected patients who have developed severe lung damage and who have elevated blood IL-6 levels.
According to the latest research outcomes the raised level of IL-6 biomarker is an indication for high levels of immune response and inflammation which is associated with a higher fatal outcome for people with community-acquired pneumonia (CAP).
The approval of Actemra comes from China’s hope that the systemic inflammatory response can be avoided as Roshe’s anti-inflammatory drug is expected to disrupt the ‘cytokine release syndrome’ (CRS) which can appear as a complication of some diseases or infections.
The previous approval in CRS has motivated the introduction of the medication in the new treatment recommendations for COVID-19 released earlier this week by the National Health Commission of China.
The use of Actemra in COVID-19 infections is not yet confirmed by efficacy or safety data. However, an initial clinical trial carried out on 188 COVID-19 infected patients by Chinese researchers showed promise. In 14 patients the preliminary results have shown that for the subjects who have severe lung disease Actemra treatment may be able to help.
Actemra available since 2010
Actemra, which is marketed in Europe as RoActemra, has been available since 2010 and was a $2bn-plus seller across its range of licenced indications last year. The European Medicines Agency has approved RoActemra as an effective treatment for reducing symptoms of several inflammatory conditions.
It was initially authorized as a treatment for rheumatoid arthritis by the US Food and Drug Administration (FDA), and subsequently earned additional approvals for cancer-related CAR-T cell therapies in juvenile idiopathic arthritis, giant cell arteritis, and CRS. Roche announced in a post that it had donated nearly $2 m worth of Actemra to China to help the country tackle the COVID-19 outbreak.
The Actemra authorisation news came soon after the World Health Organization (WHO) raised its mortality rate estimate with the novel coronavirus from approximately 2% to 3.4% worldwide, with a spectrum of 0.7%-4.0% depending on access to health services. Seasonal flu, by comparison, has a mortality rate of less than 1 percent, WHO estimates.
Other COVID-19 treatment developments
Meanwhile, Takeda and Alnylam have also joined the pharma and biotech companies developing drug treatments for COVID-19 infections.
Takeda has initiated the development of a plasma-derived therapy for COVID-19 infected high-risk individuals, which is a passive immunotherapy using a polyclonal hyperimmune globulin (H-IG), named TAK-888.
The passive immunotherapy is created from the plasma obtained from recovered patients who have pathogen-specific antibodies synthesised as an immune response whilst fighting the COVID 19. By transferring the antibodies to a new patient, it may help that person’s immune system respond to the infection and increase their chance of recovery.
Furthermore, Alnylam Pharmaceuticals says it is working with Vir Biotech on RNA interaction drugs targeting ‘ highly conserved regions ‘ of COVID-19 RNA. Both companies are already collaborating together on RNAi anti-hepatitis B virus drugs.