Remdesivir Surrenders Orphan Drug Status
Gilead antiviral remdesivir evaluation focuses on coronavirus patients
The producer of an experimental COVID-19 disease treatment announced an unusual procedural action today.
Gilead Sciences submitted a request to the U.S. Food and Drug Administration (FDA) on March 25, 2020, to rescind the Orphan Drug Designation it was recently granted for the investigational antiviral remdesivir.
Furthermore, Gilead said it is waiving all benefits that accompany this FDA designation, which include substantial economic opportunities.
Remdesivir is an antiviral medicine that is being studied in clinical trials as a possible treatment for COVID-19 around the world, including China.
On February 26, 2020, Gilead announced the initiation of two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19.
Orphan drug status is generally for situations where the disease affects fewer than 200,000 patients in the USA.
Moreover, they are among the most expensive pharmaceutical products, in part because they are shielded from generic competition for longer than other prescription medicines.
Gilead’s request indicates the company is confident that it can maintain an expedited development timeline in seeking regulatory review of remdesivir, without the orphan drug designation.
Gilead says ‘recent engagement with regulatory agencies has demonstrated that submissions and reviews relating to remdesivir for the treatment of COVID-19 .... are being expedited.’
Recently, Gilead announced they are transitioning from Individual Compassionate Use requests for remdesivir to Expanded Access Programs.
This change should enable accelerated access to remdesivir for severely ill coronavirus patients.
Throughout this program transition period, Gilead announced on March 22, 2020, is unable to accept new individual compassionate use requests due to overwhelming demand.
COVID-19 disease medication and vaccine development news published by Precision Vaccinations.