Developers request revocation of remdesivir’s ODD for COVID-19
Gilead Sciences say they are confident they can maintain an expedited regulatory review timeline for remdesivir as a treatment for COVID-19 without Orphan Drug Designation (ODD).
The producers of remdesivir, an investigational antiviral medication, have requested the US Food and Drug Administration (FDA) rescind the Orphan Drug Designation (ODD) it was granted for the treatment of COVID-19.
According to the Gilead Sciences, who produce remdesivir, their recent interactions with regulatory agencies has demonstrated that submissions and reviews relating to the drug for the treatment of COVID-19 are being expedited. The company submitted the request as the they are confident that they can maintain an expedited regulatory review timeline without ODD. As such they are waiving all benefits associated with the designation.
ODD is granted by the FDA in situations where the disease that may be treated affects fewer than 200,000 patients in the US. Technically the ODD still applies to remdesivir as the most recent statistics indicate the number of active cases is 61,808.1
One of the benefits of ODD is that the requirement of a paediatric study plan is waived prior to the submission of a New Drug Application.
Gilead stated that they recognise the urgent public health needs posed by the COVID-19 pandemic and will continue to develop remdesivir as quickly as possible, providing updates as they become available.
- Coronavirus: Latest figures on new COVID-19 infections and deaths [Internet]. euronews. 25 March 2020. [Cited: 25 March 2020]. Available at: https://www.euronews.com/2020/03/25/covid-19-coronavirus-breakdown-of-deaths-and-infections-worldwide