China has given a green light to use Roche’s anti-inflammatory drug Actemra in coronavirus patients with lung complications as it tries to find ways to tackle the COVID-19 outbreak.
The rapid approval means that Actemra (tocilizumab) – an interleukin-6 inhibitor – can be used to treat patients infected with the new coronavirus who have developed serious lung damage and also have elevated levels of IL-6 in the blood.
Prior research has suggested that elevated levels of IL-6 – a biomarker for inflammation and a high-level immune response – is associated with a higher mortality rate in people with community-acquired pneumonia.
Actemra’s approval stems from China’s hope that the drug could be able to interrupt ‘cytokine release syndrome’ (CRS), a runaway form of systemic inflammatory response that can occur as a complication of some diseases or infections.
Actemra – which is sold as RoActemra in Europe – has been on the market since 2010 and was a $2bn-plus seller last year across its range of approved indications.
It was first cleared by the US Food and Drug Administration (FDA) as a treatment for rheumatoid arthritis and subsequently picked up additional approvals in juvenile idiopathic arthritis, giant cell arteritis and CRS associated with CAR-T cell therapies for cancer.
That prior approval in CRS has prompted the drug’s inclusion in China’s National Health Commission’s new treatment guidelines for COVID-19 released earlier this week.
Roche confirmed in a post that it had donated nearly $2m-worth of Actemra to China to help the country manage the COVID-19 outbreak, which at last count has claimed almost 3,200 lives out of more than 93,000 cases, 80,000 of them within China where the virus is thought to have originated.
There is no efficacy or safety data yet to support the use of Actemra in COVID-19 infections, but Chinese researchers are carrying out an 188-patient clinical trial in patients infected with the virus. Preliminary results in 14 patients have suggested however it may be able to help in subjects who have progressed to severe lung disease.
News of the approval came shortly after the World Health Organization (WHO) increased its estimate for the mortality rate with the new coronavirus from around 2% to 3.4% globally – with a range of 0.7% to 4.0% depending on access to health services. For comparison, seasonal flu has a death rate of around 1%.
In the meantime, Takeda and Alnylam have joined the companies working on drug treatments to tackle COVID-19 infections.
Takeda has started developing a plasma-derived therapy – a polyclonal hyperimmune globulin called TAK-888 – that is intended to treat high-risk individuals with the virus. The passive immunotherapy is produced from pathogen-specific antibodies from plasma collected from recovered patients.
Alnylam meanwhile says it is working with Vir Biotech on RNA interference drugs targeting ‘highly-conserved regions’ of COVID-19 RNA. The two companies are already working together on RNAi drugs against hepatitis B virus.