On March 25, gilead announced that it had filed an application with the U.S. Food and Drug Administration (FDA) to revoke Remdesivir’s certification of orphan drugs and waive all rights related to the eligibility of orphan drugs.
(Original title: Gilead applies for revocation of Redsey Orphan Drug certification, confident of fast passing compliance review)
Journalist Cheng Tianmeng Comprehensive Report
On the morning of March 24, Beijing time, the FDA announced that it had approved the certification of orphan drugs for the treatment of the potentially effective drug Redcivir, an indication of a new type of coronavirus pneumonia (COVID-19).
Redsey’s fda-approved certification of orphan drugs has caused controversy.
Having an orphan drug would speed up the clinical use of Redsey’s treatment of new coronary pneumonia, but it also allows Gilead to protect Redsiewe exclusively from other generic drug makers from offering Ridsywe generics. Some in the industry worry that the eligibility of orphan drugs could affect Redsey’s supply.
After announcing the application to revoke the certification of the orphan drug, Gilead said in a statement, “Gilead is confident that it will be quick to get Ridsieto through the compliance review as soon as possible without the need for orphan drug eligibility.” Recent contacts with regulators have shown that approval and review of Redsie-related treatments for new coronary pneumonia are accelerating. “
In early March 2020, As a potential treatment for new coronary pneumonia, Gilead applied for and obtained an FDA-granted orphan drug for Redciway, the statement said. In the United States, the number of patients affecting new coronary pneumonia is less than 200,000. The benefit of orphan drug eligibility is that a pediatric research program is not required before a new drug application is submitted, and the program can take up to 210 days to review the program.
Orphan medicine refers to the drug used to prevent, treat and diagnose rare diseases, which are a class of very low incidence of diseases, also known as “orphan diseases.” In the United States, rare diseases are the type of disease in which fewer than 200,000 people are sick, and incentives for the development of rare disease drugs include various clinical development incentives, such as tax credits related to clinical trial costs, FDA user fee waivers, and FDA assistance in clinical trial design. and a seven-year market exclusive period for approved indications after the drug is launched.
Gilead said in a statement that Gilead recognized the urgent public health needs of the new coronary pneumonia outbreak. The company is currently moving forward with the development of Redsey and releasing information as soon as it becomes available.
Redsywe, an experimental antiviral drug being developed by Gilead, is not on the market and has previously been used in clinical trials against Ebola virus infection. In vitro and animal studies, severe acute respiratory syndrome (SARS) coronavirus and Middle East Respiratory Syndrome (MERS) coronavirus were shown to have good antiviral activity.
Since the outbreak of new coronary pneumonia, Redcievir has been considered the most promising drug in the study. Earlier, the World Health Organization in China after the outbreak said that Redciewe may be the only effective treatment of new coronary pneumonia. In January, U.S. researchers used redsieweve on a new coronavirus infection based on the principle of “sympathetic medication”, and the drug’s symptoms improved significantly in a day or two.