With the spread of the epidemic, more than 10000 confirmed patients were added in the United States yesterday, with a total of more than 40000 confirmed patients.
In this emergency, novel coronavirus pneumonia was approved by FDA in March 23rd, and the approved status was: Reed was not approved for orphan drug (rare disease) symptoms in March 23rd. Now redsiway has become the hope of the Mg people.
As early as September 2015, FDA granted redcivir orphan drug qualification for fighting Ebola virus!
Remdesivir is a drug developed by Gilead science. Remdesivir is a nucleoside analogue with antiviral activity. In hae cells, the EC50 value for SARS CoV and mers cov is 74 nm, and in delayed brain tumor cells, the EC50 value for mouse hepatitis virus is 30 nm (source: Baidu Encyclopedia).
On March 23, more than 10000 confirmed patients were added in the United States, with a total of more than 40000 confirmed patients
Data source: today's headlines
About orphan drug Grant:
When FDA reviews requests for designated orphan drugs, it will consider the mechanism of action of the drug to determine the unique disease or condition that the drug is used to treat, diagnose or prevent. Judging whether a drug can be granted orphan medicine for a unique disease or condition according to the existing medical status depends on many factors, which have been comprehensively evaluated, including: the pathogenesis of the disease or condition; The course of a disease or condition; Prognosis of disease or condition; And drug resistance. These factors are analyzed when specific drugs need to be specified.
In reviewing applications for orphan drugs, if the latest scientific literature on a specific disease or condition is rich, FDA may have a new understanding of the nature of the disease or condition. The following is a list of some diseases or conditions from the FDA's point of view on how to classify or understand diseases or conditions. This is not a comprehensive list of orphan diseases, but a reflection of some common problems we have received. FDA will appropriately update this list when making orphan drug identification decisions to change our treatment of related diseases or conditions. For a complete list of orphan drug names and approvals, see the searchable orphan product name database.
reference:
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/listResult.cfm
https://www.fda.gov/industry/designating-orphan-product-drugs-and-biological-products/orphan-drug-designation-disease-considerations
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