Gilead Redsiewe is eligible for FDA orphan drug, expected to be market-exclusive for 7 years

On March 23, the FDA's website database showed that the FDA granted Gilead Sciences the qualification for the antiviral therapy reedsion drug Redesivir, whose indications are coronavirus disease 2019 (COVID-19)FDA's Orphan Drug Qualification Program is designed to promote the development of drugs or biological products that treat rare diseases or conditionsA rare disease is defined as less than 200,000 people in the United StatesThe in-research therapy, which is eligible for orphan medicine, offers a range of benefits to promote drug development, an important of which is that if the treatment is approved, the drug can enjoy a seven-year market-exclusive period for this indicationThis means that if the FDA approves Redciewe for the treatment of COVID-19, generic drugs developed by other pharmaceutical companies will not be available in the U.Swithin seven yearsIn addition, in the course of drug development, the research and development company is able to obtain tax credits related to qualified clinical testing, as well as other benefits such as specific fee reductions when applying for new drugsRedciewe, developed byGilead Sciences, has recently become a hot topic of concernIt is an antiviral therapy whose mechanism is to inhibit the activity of RNA-dependent RNA polymerase, thereby inhibiting the proliferation of RNA virusesGilead is currently working on six clinical trials to test the efficacy of Redcywe's treatment of different types of COVID-19 patientsOf these, two clinical trials in China are expected to be completed in Aprilto meet potential future demand, the company has expanded its production capacity in Redsyway and will produce two Redsie formulations (liquid and freeze-dried)Yesterday, the company said it was currently providing a personal sympathetic use of the emergency channel to the extended use project, which will speed up access to Rhedesiweand for seriously ill patients and collect data on all involved patientsThese projects are currently being developed rapidly in conjunction with national regulators around the worldReferences:Retrieved 2020-03-24, original title https:// : Redsyway is eligible for FDA orphan drug today and is expected to be marketed for seven years