At 4:30 a.m. Beijing time on March 24, the U.S. Food and Drug Administration (FDA) announced that it has approved the certification of Remdesivir orphan drug certification by Gilead Sciences of the United States, with the conditions of a new coronavirus pneumonia (COVID-19). 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.
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.
Most importantly, the United States provides a fast-track approval channel for applications for new drug applications for orphan drugs, which can enjoy a variety of accelerated review policies in clinical trial filings. This means that the registration process for Redsiewe will be greatly accelerated after the certification of orphan drugs.
On February 26, Gilead Sciences (Nasdaq: GILD) announced on its website that it had launched two Phase III clinical studies to assess the safety and efficacy of Redcievir in treating adult cases infected with the new coronavirus.
Starting in March this year, these randomized, open, multi-center studies will be conducted in medical institutions, mainly in Asian countries, as well as in other countries with high number of confirmed cases around the world, with a population of about 1,000 patients. The study will assess the effects of Redcivir during the injection time of both drugs. The main endpoint of the two studies was clinical improvement.