What that specialty status will actually mean for the marketing or profitability of the Gilead Science's experimental drug remdesivir isn't clear. The drugmaker did not immediately respond Tuesday to requests for comment.
Experts who have studied the so-called “orphan drug” program say the company's request — and the
A financial analyst, though, called Gilead's request “pretty standard.”
The FDA granted the status on Monday, according to the agency's website. If approved for coronavirus,
The FDA defines a rare disease as one with fewer than 200,000 patients in the
“It seems like a misuse of the Orphan Drug Act, even though technically it’s within the bounds of the law,” said Dr.
Kesselheim said a number of the early AIDS drugs also received orphan drug status in the 1980s and 1990s, but then went on to generate billions in sales.
But
“It says nothing about profiting off of the pandemic, but it does provide protection if remdesivir turns into a business in subsequent years," he said.
In recent years the orphan drug program has come under scrutiny from the media,
The non-profit Public Citizen group said in a statement that the
Gilead's chairman and CEO,
“The topic of pricing comes up once you know the medicine works,” he said.
Remdesivir, given through an IV, is being tested in at least five separate experiments, and Gilead also has provided it to several hundred severely ill COVID-19 patients in the
The drug interferes with virus reproduction and has shown some promise in lab and animal studies against other coronaviruses that cause similar diseases, MERS and SARS. It was also used briefly in some Ebola patients in Congo.
For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia. The vast majority of people recover.
Day said earlier this month at a press conference with other drug industry executives that his company has been working on the drug's development for a decade. He said Gilead has spent “really billions of dollars” developing the drug and plans to spend even more to scale up manufacturing facilities at Gilead and its partners.
Gilead didn’t respond to questions seeking more details about the company’s spending on remdesivir, including whether the figures used by O’Day included the
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