In this news, we discuss the EU urged to review remdesivir supply deal after COVID-19 trial results.
BRUSSELS (Reuters) – The European Union is set to renegotiate a € 1 billion ($ 1.2 billion) contract it sealed last week with Gilead for a six-month supply of the COVID-19 drug remdesivir , after showing poor results in a large trial, experts said on Friday.
In a blow to one of the few drugs used to treat people with COVID-19, the solidarity trial conducted by the World Health Organization showed that remdesivir appeared to have little or no effect on mortality or length of hospital stays in patients with respiratory problems. disease.
The results of the trial were disclosed a week after the EU Executive Board announced its biggest contract to date with Gilead GILD.O for the supply of 500,000 courses of the antiviral drug at a price of 2,070 euros per treatment. , which Gilead said was the norm for the wealthy. nations.
The Commission “must present the reasons for the rush to conclude the latest contract with Gilead and undertake to examine it in light of the findings of the solidarity trial,” said Yannis Natsis, who represents patient organizations on the board of the European Medicines Agency (EMA), the European medicines regulator.
The EU announced on October 8 that it had signed the supply contract with the US company on behalf of its 27 member states and 10 partner countries, including Britain.
Gilead had known about Solidarity’s results since Oct. 6, the WHO said, citing disclosure rules in the Solidarity trial.
Gilead told Reuters he received a “heavily edited manuscript” from the WHO in late September that contained information different from the outcome document released on Friday.
‘TIME IS OF THE ESSENCE’
The Commission’s decision came after EU countries warned of shortages of remdesivir in their hospitals amid a new surge in COVID-19 infections across Europe.
The contract does not oblige countries to purchase remdesivir, although it does tie them to the agreed price.
Two days after the deal with the EU, Poland said it had ordered 80,000 vials of remdesivir, which is typically given on a six-dose schedule.
Gilead said he did not plan to adjust the price of remdesivir for wealthy countries after the WHO trial, and the company questioned its results.
“Time is running out – we are in a public health emergency – we must not only invest upstream in the development of vaccines but also in access to therapies,” said a spokesperson for the European Commission.
He added that the EMA would review Solidarity’s results and the data available from other studies on COVID treatments “to see if changes are needed in the way these drugs are used.”
But the spokesperson did not say whether the EU was aware of Solidarity’s results before signing the contract with Gilead. He also did not respond to questions about whether the price agreed with Gilead could be renegotiated.
“The EU should review the prices to be paid for Remdesivir. Why pay 1 billion euros for a drug with no effect on survival? Said Andrew Hill, Visiting Principal Investigator in the Department of Pharmacology at the University of Liverpool.
He said generic versions of the drug made in India were sold for 200 euros per course.
(1 USD = 0.8525 euros)
Reporting by Francesco Guarascio @fraguarascio; additional reports by John Miller and Anna Koper; Edited by Gareth Jones, Louise Heavens and Mark Potter
Original © Thomson Reuters