FDA rejects oleandrin as a dietary supplement, after being touted by major Trump ally as a coronavirus treatment
pharmafile | September 7, 2020 | News story | Sales and Marketing | FDA, coronavirus, fda treatment
The FDA has rejected a submission from Phoenix Biotechnology to market oleandrin as a dietary supplement.
Phoenix Biotechnology submitted oleandrin to the FDA to be approved as a supplement on 2 June. The FDA response letter was sent on 14 August and published last week, saying that as the company had already tested oleandrin as a potential prescription drug it could not seek permission to sell it as a supplement at the same time.
Oleandrin is made from the toxic shrub known as the oleander plant and is currently being used as an active principle ingredient in Phase 1 and Phase 2 cancer trials. It is also being tested in a lab as an antiviral treatment that could be used to alleviate coronavirus symptoms. Currently, there are no peer reviewed studies of the treatment being tested in human patients.
The FDA letter concluded: “Studies performed in advanced cancer patients generally cannot establish the safety of your ingredient in its intended population of normal healthy adults, and you did not provide any information to indicate that such extrapolation between different populations would be scientifically valid.”
The drug has made the headlines recently, as Mike Lindell, a prominent Trump ally, said he had asked the President to consider approving the treatment as a potential therapeutic for coronavirus in July.
When Trump was asked by reporters about oleandrin, he said: “We’ll look at it, we’ll look at it, we’re looking at a lot of different things. I will say the FDA has been great. They are very close. We’re very close to a vaccine. Very close to a therapeutic. I have heard that name mentioned, we’ll find out.”
Lindell is the CEO of MyPillow but recently joined the board of Phoenix Biotechnology which makes oleandrin. He is also serving as the Chairman of the Trump 2020 re-election campaign in Minnesota, and told the press that Trump was “enthusiastic” about the FDA approving the treatment for treating the virus.
Conor Kavanagh
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