China approves use of Roche drug in battle against coronavirus complications

[March 04, 2020]  By Roxanne Liu and John Miller

BEIJING/ZURICH (Reuters) - China has approved the use of Swiss drugmaker Roche's <ROG.S> anti-inflammation drug Actemra for patients who develop severe complications from the coronavirus as it urgently hunts for new ways to combat the deadly infection that is spreading worldwide.

China is hoping that some older drugs could stop severe cytokine release syndrome (CRS), or cytokine storms, an overreaction of the immune system which is considered a major factor behind catastrophic organ failure and death in some coronavirus patients.

Actemra, a biologic drug approved in 2010 in the United States for rheumatoid arthritis (RA), inhibits high Interleukin 6 (IL-6) protein levels that drive some inflammatory diseases.

China's National Health Commission said in treatment guidelines published online on Wednesday that Actemra can now be used to treat coronavirus patients with serious lung damage and high IL-6 levels.

Separately, researchers in the country are testing Actemra, known generically as tocilizumab, in a clinical trial expected to include 188 coronavirus patients and running until May 10.

Roche, which donated 14 million yuan ($2.02 million) worth of Actemra during February, said the trial was initiated independently by a third party with the aim of exploring the efficacy and safety of the drug in coronavirus patients with CRS.

It added that there was currently no published clinical trial data on the drug's safety or efficacy against the virus.

More than 3,000 people have died and 93,000 have been infected by the novel coronavirus thought to have originated in Wuhan, China, before spreading to around 90 countries including the United States, Italy, Switzerland, France and Germany.

The Swiss company, for which China is its No. 2 market behind the United States, also makes diagnostic gear to detect the coronavirus.

Since Actemra's approval a decade ago, it has become a go-to drug against other inflammatory conditions, including cytokine storms in cancer patients receiving cell therapies from Novartis <NOVN.S> and Gilead Sciences <GILD.O>.

In 2012 it helped save the life of a young U.S. girl, the first child to be treated for leukaemia with Novatis' Kymriah, from a post-treatment rush of IL-6.

Priced at between $20-30,000 annually for RA according to SSR Health, Roche's medicine is also used for rare juvenile arthritis and giant cell arteritis, or inflammation of the blood vessels.

China's National Medical Product Administration has yet to give its approval for Actemra to be sold for use in coronavirus infection cases and Chinese drugmakers are also racing to develop alternatives to Roche's treatment.

Bio-Thera Solutions Ltd <688177.SS> expects to file new drug approval for a version of Actemra in 2021, while Zhejiang Hisun Pharmaceutical Co Ltd <600267.SS> in 2016 got regulatory approval to hold trials for an Actemra copy, company filings showed.

($1 = 6.9293 yuan)

(Reporting by Roxanne Liu and Brenda Goh in Beijing, additional reporting by John Miller in Zurich; Editing by Se Young Lee, Stephen Coates, Kirsten Donovan)

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