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Gilead Sciences said it was confident that the Redsewe regulatory review process would be accelerated even without the status of orphan drugs.
recent exchanges with regulators indicate that applications and reviews related to Redsewe's treatment of COVID-19 will be expedited.
In early March, Gilead Sciences sought fda status for orphan drugs to develop Redsewe as a potential treatment for COVID-19.
Orphan Drug Qualification is one of the FDA's measures to encourage the development of treatments for rare diseases, providing pharmaceutical companies with a variety of preferential policies for the development of research therapies.
one of the benefits is to avoid submitting a pediatric research program before applying for a new drug.
process of review spent up to 210 days. "Gilead recognizes the urgent public health needs of the COVID-19 pandemic,"
Gilead Sciences said in a statement.
is moving forward with Redsewee as quickly as possible.
" Redsewe is a widely-watched antiviral research therapy that is currently being tested in six clinical trials to treat different types of COVID-19 patients.
, two clinical trials in China are expected to produce results in April.
References: Gilead Sciences Statement on Request to Rescind Remdesivir Orphan Drug DeIty.
Retrieved March 25, 2020, from the original title: Burst! Gilead asked for the Dedesewe orphan drug to be disqualified.