EMA Reviewing Two MAb Combinations For COVID-19

Products Being Assessed Under Special Procedure For EU Member States

The European Medicines Agency's special review process that was used to help EU member states issue emergency use approvals for dexamethasone in COVID-19 patients is now being applied to two antibody combinations from Regeneron/Roche and Lilly.

European Union flag with covid-19 coronavirus in background
More products for use in COVID-19 are being assessed in Europe • Source: Shutterstock

The European Medicines Agency is carrying out a review of two monoclonal antibody combinations with potential in treating COVID-19, under a special procedure that assists the EU member states in making medicinal products available in emergency situations before they have been formally approved.

The two combinations in question are casirivimab/imdevimab and bamlanivimab/etesevimab. The first is being co-developed as REGN-COV2 by 

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

EU Medical Countermeasures Strategy Promises More AMR Pull Incentives

 

A new EU strategy to ensure access to essential medicines will boost the development of critical medical counter measures, including vaccines and therapies, according to one pharmaceutical industry group.

Animal Testing: US And EU Regulatory Support Grows For Alternatives, But Validation A Hurdle

 

In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.

AI And Inertia: The Disruptors Keeping EU Regulators Awake At Night

 

Data is “the new oil,” but its use will challenge regulators, while inertia is the biggest disrupter of all for European regulators, according to European Medicines Agency chiefs past and present.

More from Geography

EMA’s PRIME Scheme Explored: Growing Designations - But Are Accelerated Assessments Slipping?

 

While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.

Global Pharma Guidance Tracker - June 2025

 

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.