Gilead's Remdesivir Granted FDA Orphan Drug Designation for COVID-19, Eligible for 7-Year Market Exclusivity

From Jike Pharmaceutical News

On March 23, the FDA’s official website database showed that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to remdesivir, an investigational antiviral therapy developed by Gilead Sciences, Inc., for the treatment of coronavirus disease 2019 (COVID-19).

The FDA’s Orphan Drug Designation program is designed to promote the development of drugs or biological products for treating rare diseases or conditions. A rare disease is defined as one that affects fewer than 200,000 people in the United States. Investigational therapies granted orphan drug status are eligible for a range of incentives to facilitate drug development. A key benefit is that, upon approval for the orphan indication, the drug receives seven years of market exclusivity for that indication. This means that if the FDA approves remdesivir for the treatment of COVID-19, generic versions developed by other pharmaceutical companies cannot be marketed in the United States for seven years. Additionally, during the drug development process, sponsoring companies can receive tax credits for qualified clinical testing and fee waivers associated with submitting a New Drug Application, among other benefits.

Remdesivir, developed by Gilead Sciences, Inc., has recently become a focal point of public attention. It is an antiviral therapy that works by inhibiting the activity of RNA-dependent RNA polymerase, thereby suppressing the replication of RNA viruses. Currently, Gilead is conducting six clinical trials to evaluate the efficacy of remdesivir in treating patients with different types of COVID-19. Among these, two clinical trials being conducted in China are expected to yield results in April.

To meet potential future demand, the company has expanded its remdesivir production capacity and will manufacture two formulations of remdesivir (liquid and lyophilized). Yesterday, the company stated that it is currently transitioning from providing individual compassionate use emergency access to expanded access programs. This approach will accelerate access to remdesivir for critically ill patients and enable the collection of data on all participating patients. These programs are currently being rapidly developed in collaboration with regulatory authorities worldwide.

References:

[1] Designating an Orphan Product: Drugs and Biological Products. Retrieved 2020-03-24, from https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=739020

Original Title: Remdesivir Receives FDA Orphan Drug Designation Today, Potentially Qualifying for 7-Year Market Exclusivity

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