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Regulatory Focus™ > News Articles > 2020 > 3 > COVID-19 therapeutics tracker

COVID-19 therapeutics tracker

Posted 23 October 2020 | By Jeff Craven 

COVID-19 therapeutics tracker

Months into the COVID-19 pandemic, just three therapeutics have been approved to treat COVID-19: dexamethasone in the United Kingdom and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the United StatesJapan and Australia.
 
Convalescent plasma may be used in the US to treat hospitalized patients under an emergency use authorization (EUA) or an investigational new drug application (IND). “Adequate and well-controlled randomized trials remain necessary for a definitive demonstration of COVID-19 convalescent plasma efficacy and to determine the optimal product attributes and appropriate patient populations for its use,” according to updated guidance issued by the US Food and Drug Administration (FDA) on 2 September.

Several large international trials are underway. The largest, SOLIDARITY, is led by the World Health Organization (WHO). More than 100 countries have joined SOLIDARITY to evaluate high-profile treatment candidates for COVID-19.
 
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The pandemic has created unprecedented public/private partnerships. Operation Warp Speed (OWS) is a collaboration of several US federal government departments including Health and Human Services and its subagencies; Agriculture; Energy; and Veterans Affairs; along with private sector enterprises. Within OWS, the US National Institutes of Health (NIH) has partnered with more than 18 biopharmaceutical companies to accelerate development of drug and vaccine candidates for COVID-19 in a collaboration dubbed Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV).
 
In July 2020, the European Medicines Agency (EMA) issued a conditional marketing authorization for Veklury to treat COVID-19 in adults and adolescents aged at least 12 years with pneumonia who require supplemental oxygen. After reviewing RECOVERY trial results, EMA concluded in September 2020 that dexamethasone can be used to treat hospitalized patients at least 12 years old with COVID-19 who require respiratory support. Clinical trials are ongoing in the European Economic Area for systemic interferons, monoclonal antibodies and antivirals.
 
Once a leading candidate, hydroxychloroquine/chloroquine has been removed from the tracker due to evidence it can cause more harm than benefit in patients with COVID-19. It will be reinstated if evidence to the contrary arises.
  
This tracker will be updated weekly with the latest in developments for treatment candidates who have advanced to at least Phase 1 study. If you notice an issue with this data or wish to submit an update, please email Focus at news@raps.org.
 
Updated 23 October to include new information on Veklury, Kaletra, Actemra, AZD7442, Remicade and Pepcid (famotidine). 

 

 

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