FDA approves first treatment for Ebola
Food and Drug Administration (FDA) officials approved the first treatment for Ebola on Wednesday.
Regulators greenlit a trio of antibody drugs developed by Regeneron to treat the hemorrhagic fever virus that has killed tens of thousands of people in West Africa, and is up to 90 percent fatal.
Regeneron is making another antibody to treat the newest viral threat to humanity, COVID-19, but the two treatments are entirely unrelated.
Ebola patients treated with Regeneron’s antibody ‘cocktail’ in trials were one third less likely to die than were people who did not get the drug.
Although a vaccine against Ebola was approved in December of last year and was declared officially ‘over’ in June, has been little doctors could do to improve survival odds for someone who does catch the devastating virus.
‘It’s still pretty terrifying’ said former Food and Drug Administration (FDA) associate commissioner Peter Pitts of Ebola.
‘If there is an approved treatment for it, that’s as close to a miracle as you get.’
He reiterated that the approval for a Regeneron antibody cocktail for treating Ebola was entirely coincidental and unrelated to COVID-19 treatments.
Afterall, ‘Ebola is a death sentence, COVID-19 is not,’ he added.
FDA regulators on Wednesday approved Inmazeb, an antibody ‘cocktail’ and the first drug with officials’ seal of approval for treating Ebola. It cuts death rates from the disease by about 30%
West Africa has been hit by a series of episodes of Ebola that have reached epidemic levels, and even bordered on pandemic levels.
The 2014-2016 outbreak spread to 28,616 people and killed 11,310 people across the neighboring nations of Guinea, Liberia and Sierra Leone.
Ebola crept outside of those nations’ borders too, with 36 cases and 15 deaths across the rest of the world, including 11 cases and one death in the US in 2014.
Cases of the viral disease spiked again in 2018-2019. Nearly 3,300 people were infected, primarily in the Kivu region of the Democratic Republic of Congo.
Two-thirds of people who contracted the virus died.
Ebola’s source is unclear coronavirus, it may well have made the jump to humans from bats.
It spreads via blood following contact with blood, tissue and bodily fluids.
That makes it particularly dangerous because a cough, sneeze, cut or sex can all spread Ebola.
Its first symptoms are not unlike the flu (or, for that matter, COVID-19), and include fever, aches, paines, headache, muscle and joint pain, stomach pain, diarrhea, vomiting and sudden bleeding or bruising.
Ebola’s attacks on the body prevent the blood from clotting. As a result, blood can leak from small vessels throughout the body.
Ebola is highly contagious and can have a fatality rate as high as 90%. Tens of thousands of people died in outbreaks of the disease in West Africa
Blood loss and resulting septic shock, seizures, brain inflammation, and organ failure are all common and often deadly outcomes of the disease.
Regeneron developed several monoclonal antibodies – lab-made immune proteins that fight infection – designed to block the Ebola virus from infecting human cells.
In a late-stage trial, the drug – known as Inmazeb – was given to half of a group of 382 adult and child Ebola patients.
More than half (51 percent) of those who were given a placebo treatment died of the horrible viral infection
By comparison, only about a third of those who got the antibody treatment perished.
Regeneron’s antibody treatments became among the most promising being developed to fight Ebola last year.
Inmazeb was given the FDA’s ‘breakthrough therapy’ designation and in April of this year, the agency accepted Regeneron’s application for approval.
The company was promised a verdict by October 25, putting Wednesday’s approval just days ahead of schedule.
It’s certainly a win for Regeneron, whose shares rose about half a percent after the bell, and the approval, but it will have ‘no impact or interference to Regeneron’s program in terms of addressing COVID-19,’ Pitts told DailyMail.com.
‘They’ve had an outsize voice in moving forward this type of science, seeing as how it’s a relatively small company.’
‘Giving people a radically enhanced chance of survival relative to Ebola is a Nobel Prize-winning proposition.’
Regeneron also filed an application for emergency FDA approval of its antibody therapy for COVID-19 last week, but data on that drug’s effects remains relatively limited.
Neither the FDA nor Regeneron has offered any sense of when the drug might be approved (or denied), although President Trump said Wednesday that he is seeking emergency approval for the drug.
The president does not have regulatory authority to approve the drug, and it is Regeneron that is seeking approval for it.