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Actemra and other rheumatoid arthritis drugs
Doctors in China have used an anti-inflammation drug to curb the effects of the coronavirus on critical patients, and now the maker of the drug says it is talking to the Food and Drug Administration about clinical trials.
Tocilizumab, sold under the name Actemra and made by the Swiss pharmaceutical firm Roche, is a prescription medicine used to treat adults with moderate to severe active rheumatoid arthritis, as well as certain types of juvenile arthritis.
Chinese doctors have used Tocilizumab to prevent an overreaction of the immune system that has led to organ failure and death in coronavirus patients. An initial clinical trial in China used Actemra in 20 severe COVID-19 cases. Nineteen of the patients were discharged from the hospital within two weeks and one got better, according to China’s National Health Commission. The drug has now been approved for use in China, but has not yet been approved in the United States.
Karsten Kleine, a spokesperson for Roche, told NBC News that the drug company “is in active discussions with the FDA, as well as government bodies and institutions around the world, to initiate clinical trials that evaluate the safety and efficacy of Actemra (tocilizumab) for the treatment of severely ill COVID-19 patients.”
Roche is not alone in looking into rheumatoid arthritis drugs as a potential treatment. Sanofi and Regeneron are launching a clinical trial in New York to see if their rheumatoid arthritis drug Kevzara is effective.
AbbVie, the creator of HIV drugs Kaletra/Aluvia, is collaborating with health authorities to determine the efficacy of using its HIV drugs to treat COVID-19. The company is working with the FDA, CDC, and European agencies to set up clinical trials of the drug.
At this time, AbbVie told NBC News it cannot confirm Chinese media reports that the drug has been successful in treatment as it does not have access to Chinese clinical information. It is monitoring its current supply to make sure current HIV patients being treated by the drug will not be affected by an increase in demand.
Sanofi is assessing the risk and benefit of its malaria drug hydroxychloroquine for the management of coronavirus. According to the company, some health authorities are allowing the temporary use of chloroquine for the management of COVID-19, but there is insufficient data to draw any conclusions over its efficacy. Any use of the drug in this context is considered “off-label” use.
Based on encouraging preliminary findings from a study in France, Sanofi is looking at ways to collaborate and partner with health authorities investigating the use of hydroxychloroquine for the management of coronavirus.
Remdesivir is a broad spectrum anti-viral medication developed by Gilead Sciences as a treatment for Ebola and also showed success in treatment of monkeys infected with MERs, a different type of coronavirus. It is now being tested as a potential COVID-19 treatment.
Remdesivir is in clinical trials in China and the U.S. at the University of Nebraska Medical Center. There are 20 locations involved in the trial and seven are recruiting for participants, including Emory Vaccine Center in Atlanta and The University of Washington Virology Research Clinic. All participants must have laboratory-confirmed SARS-CoV-2 infection with symptoms showing evidence of lung involvement, rattling sounds when breathing with a need for supplemental oxygen or abnormal chest X-rays, or illness requiring mechanical ventilation.
The first participant is an American who was on the Diamond Princess cruise ship that docked in Yokohama, Japan.
Those with a confirmed infection who have mild symptoms or no apparent symptoms at all cannot participate in the study.
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