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EU Approves Gilead’s Remdesivir For COVID-19 In Record Time

Despite The Controversy, Blockbuster Status Is Predicted

 
• By Andrew McConaghie

The EU has granted conditional marketing approval to Gilead’s drug, which has the brand name Veklury. It will cost about €2,000 per treatment.

Vials_Remdesivir
There are concerns over the supply of remdesivir for COVID-19 • Source: Shutterstock

The European Commission's decision to issue a conditional marketing authorization for Gilead Sciences Inc.'s COVID-19 therapy, Viklury (remdesivir), comes just eight days after the European Medicines Agency's drug evaluation committee, the CHMP, delivered a positive opinion on the product's approval. In normal circumstances the commission has 67 days in which to grant an MA after a CHMP recommendation. (Also see "Remdesivir’s EU Approval For COVID-19 Due Within Days" - Pink Sheet, 25 June, 2020.) 

The decision also comes just two days after Gilead announced that the US government had bought up nearly all of its current stocks of the antiviral therapy, amounting to three months’ supply

More from Europe

EU Council Could Adopt Pharma Reform Package Next Week, But Disputes Risk A Year’s Delay

 
• By Eliza Slawther

The Council of the EU wants to adopt its negotiating position on the reform of the general pharmaceutical legislation “sooner, rather than later,” but divergence between member states could push negotiations back another year, a European Commission policy officer said today.

EU HTA Regulation: How Rare Disease Drug Makers Can Meet Worrisome JCAs Data Requirements

 
• By Francesca Bruce

In an interview with the Pink Sheet, Fonadazione Telethon’s Stefano Benvenuti discusses how companies developing and marketing rare disease treatments can overcome the challenges presented by EU-joint clinical assessment evidence requirements.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.

EMA Explores Using AI Language Models To Refine Oncology Guidance

 
• By Vibha Sharma

The European Medicines Agency has for the first time explicitly stated it is considering the use of large language models as a tool to improve the readability of a scientific guideline.

More from Geography

US HHS Deputy Nominee Talks AI, Not FDA, In Confirmation Hearing

 
• By Ramsey Baghdadi

Silicon Valley investor Jim O’Neill’s Senate confirmation hearings showcased the unique background of someone with government and tech experience and avoided discussions of his past statements about lowering the bar for regulatory approval.

US FDA Waiting On Guidance Agenda Future As HHS Seeks Regulation Cuts

 
• By Derrick Gingery

The FDA continues to wait for a decision on whether its priority guidances will be published as HHS asks the public for potential regulation cuts to fulfill President Trump’s executive order.

Austria To Fine Companies For Violating New Drug Stockpiling Rule

 
• By Neena Brizmohun

A new ordinance for addressing drug shortages in Austria requires drug companies distributing any of the hundreds of products listed in an accompanying annex to maintain adequate stock in the country to meet patient demand for four months.