Gilead Sciences’ (NASDAQ:GILD) experimental drug remdesivir, seen as one of the more promising potential treatments for the coronavirus, on Monday received the orphan drug designation from the U.S. Food and Drug Administration.
The announcement comes days after U.S. President Donald Trump called on the FDA to streamline its approval process for treatments such as remdesivir, which is currently being tested in clinical trials, with results expected as early as next month.
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.
Health officials from the World Health Officials have noted that Gilead’s remdesivir has demonstrated efficacy in treating the coronavirus infection.
Trump announced late last week that chloroquine (hydroxychloroquine/Plaquenil), a drug used to treat malaria and arthritis, had been approved by the FDAFDA to be tested as a treatment for crisis. Chloroquine is being tested in various clinical trials conducted by government agencies and academic institutions. Other antivirals drugs are also planned to be fast-tracked for testing.
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.
Gilead shares climbed $1.48, or 2%, to $74.09
