Roche’s Coronavirus Test Gets FDA Emergency Use Authorization

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Over the past few years, innovative Swiss giant Roche has combined its position as the world’s number 1 biotech company and its strength in in vitro diagnostics to brand itself as the frontrunner in personalized healthcare. In 2012, CEO Severin Schwan set the ambitious target of pairing more than 60 percent of Roche’s pipeline drugs with companion diagnostics in 2012, and the company has since made a number of strategic investments into the convergence of therapeutics and diagnostics. One of the indicators of the success of this strategy is Roche’s eighth position on the Pharmaceutical Innovation Index 2019. 

 

Over the past few years, Roche’s China affiliate – second-largest after the US affiliate – has also undergone a strategic transformation under GM Hong Chow, a Chinese-born German citizen, to “ride the wave of the recent healthcare reforms”, in her own words. Notably, the affiliate worked together with the Chinese government to receive reimbursement for some of their most innovative oncology drugs. This and other successful efforts saw the affiliate grew 28 percent in 2018 as well as a high-profile visit by Chinese Premier Li Keqiang to the Roche Shanghai HQ.

 

In 2020, as the COVID-19 pandemic causes global alarm, Roche has once again demonstrated its twin competencies in diagnostics and therapeutics – and the strategic importance of the China market. 

 

Just a couple of days ago, Roche received “emergency use authorization” from the US FDA for its enhanced coronavirus test – the first commercially available one to do so. Results can be obtained within four hours. As a press release from Roche emphasizes, “broad access to reliable COVID-19 testing is essential to accurately identify who has been infected and to contain the disease.” This is especially urgent in the US, where the US Centers for Disease Control and Prevention estimates that only around 11,000 specimens have been tested since January, compared to nearly 30,000 in the UK, and nearly 20,000 every day in South Korea.

 

At the same time, Roche has also received approval from the Chinese NMPA to use its anti-inflammation drug, Actemra®, to treat coronavirus patients with severe lung damage and high interleukin 6 (IL-6) levels. While COVID-19 affects different people differently, in some cases, some patients develop uncontrolled immune response, potentially causing life-threatening damage to lung tissue. This is what Actemra is expected to treat; it does not kill the coronavirus directly. Actemra was first approved by the Japanese PMDA in 2007, and subsequently by the Chinese NMPA in 2013. Once the potential therapeutic effect of Actemra® was announced by Chinese physicians, Roche immediately donated USD 2 million’s worth of Actemra to Chinese authorities. 

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