Gilead’s Promising Coronavirus Treatment Granted Orphan Drug Status That Provides Lucrative Incentives For Company
Gilead could keep lower-priced generic versions of the medicine off the market for several years if remdesivir is approved for use. Gilead was able to secure the status because as of now there are fewer than 200,000 cases in the U.S.
The Associated Press:
Potential Coronavirus Treatment Granted Rare Disease Status
The pharmaceutical giant that makes a promising coronavirus drug has registered it as a rare disease treatment with U.S. regulators, a status that can potentially be worth millions in tax breaks and competition-free sales. What that specialty status will actually mean for the marketing or profitability of Gilead Science’s experimental drug remdesivir isn’t clear. The drugmaker did not immediately respond Tuesday to requests for comment. (Perrone and Lardner, 3/25)
NPR:
Remdesivir Gets Rare Disease Perks From FDA
The agency's decision would provide lucrative incentives to the drug's maker, Gilead Sciences, and could keep lower-priced generic versions of the medicine off the market for several years if remdesivir is approved for use, public health advocates say. Remdesivir is an intravenous, antiviral medicine that is being studied in clinical trials around the world as a possible treatment for COVID-19. Clinical trials for remdesivir as a COVID-19 treatment got started in China in early February. Tests of the drug are now enrolling patients elsewhere, including the United States. (Lupkin, 3/24)
Reuters:
Gilead's Potential Coronavirus Treatment Gets FDA's Orphan Drug Label
The orphan drug status provides a seven-year market exclusivity period, as well as tax and other incentives for drug companies developing treatments for rare diseases that affect fewer than 200,000 people. Gilead on Sunday said it was temporarily putting new emergency access to remdesivir on hold due to an exponential increase in so-called compassionate-use requests for the drug. There are currently no approved treatments or preventive vaccines for COVID-19, the disease caused by the coronavirus. Most patients currently receive only supportive care such as breathing assistance. (3/23)
Bloomberg:
Gilead Experimental Covid-19 Drug Scores Potential Tax Break
The consumer advocacy group Public Citizen railed against the designation. “The FDA has handed Gilead, one of the most profitable pharmaceutical corporations on earth, a long and entirely undeserved seven-year monopoly and with it, the ability to charge outrageous prices to consumers,” Peter Maybarduk, a director at the group said in a statement. While Covid-19 is still relatively rare, scientists have noted that the spread is expected to pick up exponentially. Orphan drug status is part of a host of programs the agency has added in recent years to speed along new medicines. The FDA didn’t immediately respond to requests seeking comment. (Flanagan, 3/24)
