Gilead Sciences, Inc. (NASDAQ:GILD) will no longer pursue Orphan Drug Status for its antiviral drug remdesivir billed as a potential treatment for COVID-19. The pharmaceutical giant has asked the Food and Drugs Administration tasked with the responsibility of approving drugs in the U.S to retract the status approval. However, the company has confirmed plans to pursue speedy approval of the drug to address the current pandemic.
Remdesivir for Corona
By retracting the Orphan Drug Status, the company will not be able to enjoy monopoly status upon its approval for the treatment of coronavirus. Similarly, the company stands the risk of missing tax breaks of up to 25% with the drug.
Gilead would have profited exclusively for up to seven years had it gone forth with the Orphan Drug Status designation. However, such a move would have made it difficult for consumers to gain access to a much cheaper version of the drug as the status approval prohibits other pharmaceutical companies from coming up with a generic version of the drug.
The Orphan Drug Status was envisioned in law as part of an effort to encourage drug companies to come up with drugs for rare diseases affecting less than 200,000 people. The designation is designed to allow drug companies to recoup some of the development costs, given the limited market for such drugs.
However, for COVID-19, it is a completely different case. The havoc-causing virus is on course to affect more than 200,000 people, given the rate at which it is spreading. Gilead had initially applied for the Orphan Drug Status as at the time of the application, there were fewer cases. In addition, the company maintains it had applied for the designation in a bid to try to expedite remdesivir approval
The application had initially drawn political backlash prompting the pharmaceutical giant to retract its application. Remdesivir is among the very few drugs touted as a possible treatment option for the Coronavirus at a time when scientists are racing against time to come up with vaccines. The drug had previously shown effectiveness in addressing the Ebola virus.