A study being conducted by the pharma giant Eli Lilly related to an antibody drug for people hospitalised with Covid-19 is being brought to a premature closure by government officials in the United States because the treatment is apparently not helping out the patients.
Two weeks ago, a potential safety issue had forced pausing of enrollment in the study by independent monitors. However when the issue was closely examined, no safety problem was found by the National Institute of Allergy and Infectious Diseases of the US. However authorities found that the drug for which the trials were undergoing presented a low chance that it could be helpful for Covid-19 patients who are hospitalised. That prompted the recommendation for closure of the study.
Analysts and experts view this closure as a setback for a treatment approach for Cvoid-19 that was among the most promising. Earlier this month, when US President Donald Trump was sickened with the novel coronavirus, a similar experimental treatment was given to him that included two-antibody drug from Regeneron Pharmaceuticals Inc. on an emergency basis.
A separate study for testing the antibody drug in mild to moderately ill patients is currently being continued by the government, Lilly noted in a statement, which is aimed at trying to prevent hospitalization of patients and severe illness from Cvoid-19. Its own studies to test the drug are also being continued by the company. The drug is being developed in partnerhisp with the Canadian company AbCellera.
When an infection occurs in a human being, the body produces certain specific proteins which are known as antibodies. Such proteins thereby help the body to eliminate by the virus by attaching themselves to the virus and killing or supressing it. The experimental drug that Lilly is working on comprises of concentrated versions of one or two specific antibodies which were found to have worked out best against the novel coronavirus during laboratory trials and tests on animals.
An application to grant emergency use authorisation for their drugs for Covid-19 even while continuing with late stage trials and studies of the drugs with the US Food and Drug Administration have been filed by Lilly and Regeneron.
The basis of the request with the FDA for the drug is other results suggesting the drug helps patients who are not hospitalised, Lilly said and added that the company will continue to ask for permission for emergency use of the drug from the FDA.
(Source:www.thehindu.com)
Two weeks ago, a potential safety issue had forced pausing of enrollment in the study by independent monitors. However when the issue was closely examined, no safety problem was found by the National Institute of Allergy and Infectious Diseases of the US. However authorities found that the drug for which the trials were undergoing presented a low chance that it could be helpful for Covid-19 patients who are hospitalised. That prompted the recommendation for closure of the study.
Analysts and experts view this closure as a setback for a treatment approach for Cvoid-19 that was among the most promising. Earlier this month, when US President Donald Trump was sickened with the novel coronavirus, a similar experimental treatment was given to him that included two-antibody drug from Regeneron Pharmaceuticals Inc. on an emergency basis.
A separate study for testing the antibody drug in mild to moderately ill patients is currently being continued by the government, Lilly noted in a statement, which is aimed at trying to prevent hospitalization of patients and severe illness from Cvoid-19. Its own studies to test the drug are also being continued by the company. The drug is being developed in partnerhisp with the Canadian company AbCellera.
When an infection occurs in a human being, the body produces certain specific proteins which are known as antibodies. Such proteins thereby help the body to eliminate by the virus by attaching themselves to the virus and killing or supressing it. The experimental drug that Lilly is working on comprises of concentrated versions of one or two specific antibodies which were found to have worked out best against the novel coronavirus during laboratory trials and tests on animals.
An application to grant emergency use authorisation for their drugs for Covid-19 even while continuing with late stage trials and studies of the drugs with the US Food and Drug Administration have been filed by Lilly and Regeneron.
The basis of the request with the FDA for the drug is other results suggesting the drug helps patients who are not hospitalised, Lilly said and added that the company will continue to ask for permission for emergency use of the drug from the FDA.
(Source:www.thehindu.com)
