Last updated: 21 December 2021
The European Commission (EC) has established a portfolio of the ten most promising treatments for COVID-19.
A group of independent scientific experts has screened 82 therapeutic candidates in late stage clinical development and identified 10 candidates as the most promising for the EU portfolio of COVID-19 treatments, taking into account that different types of products are needed for different patient populations and at different stages and severity of the disease. The list of ten (below) is divided in three categories of treatments and will continue to evolve as new scientific evidence emerges:
| Company | Product type | Product | Regulatory status |
|---|---|---|---|
| Regeneron Pharmaceuticals and Roche | Antiviral monoclonal antibodies | Ronapreve, a combination of two monocolonal antibodies casirivimab and imdevimab | Marketing authorisation granted for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. |
| Vir Biotechnology and GlaxoSmithKline | Antiviral monoclonal antibody | Xevudy (sotrovimab) | The CHMP has recommended authorising Xevudy for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. |
| Astrazeneca | Antiviral monoclonal antibodies | Evusheld, a combination of two monoclonal antibodies tixagevimab and cilgavimab | Currently under rolling review |
| Ridgeback Biotherapeutics and MSD | Oral antiviral for use as quickly as possible after the infection | Molnupiravir | Currently under rolling review CHMP has issued advice on the use of Lagevrio for the treatment of COVID-19. The medicine, which is currently not authorised in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of developing severe COVID-19. Lagevrio should be administered as soon as possible after diagnosis of COVID-19 and within 5 days of the start of symptoms. The medicine, which is available as capsules, should be taken twice a day for 5 days. |
| Pfizer | Oral antiviral for use as quickly as possible after the infection | PF-07321332 | Has received scientific advice from EMA and once enough clinical data is collected, further rolling reviews can start. |
| Atea Pharmaceuticals and Roche | Oral antiviral for use as quickly as possible after the infection | AT-527 | As above |
| Roche Holding | Immunomodulator to treat hospitalised patients | Roactemra (tocilizumab) | CHMP has recommended extending the indication of RoActemra (tocilizumab) to include the treatment of adults with COVID-19 who are receiving systemic treatment with corticosteroids and require supplemental oxygen or mechanical ventilation. |
| Swedish Orphan Biovitrum | Immunomodulator to treat hospitalised patients | Kineret (anakinra) | CHMP has recommended extending the indication of Kineret (anakinra) to include treatment of COVID-19 in adult patients with pneumonia requiring supplemental oxygen (low or high flow oxygen) and who are at risk of developing severe respiratory failure, as determined by blood levels of a protein called suPAR (soluble urokinase plasminogen activator receptor) of at least 6 ng per ml. |
| Eli Lilly | Immunomodulator to treat hospitalised patients | Olumiant (baricitinib) | Marketing authorisation application review to extend the use of Olumiant in progress. |
| Humanigen | Immunomodulator to treat hospitalised patients | Lenzilumab | Has received scientific advice from EMA and once enough clinical data is collected, further rolling reviews can start. |
The selection of the 10 candidates is independent from and does not replace the scientific assessment by the European Medicines Agency or the authorisation of the medicines by the European Commission. A selected product may not be authorised, if the available scientific evidence does not meet the regulatory requirements.
A Q & A with further information on the list of 10 candidate COVID-19 therapeutics is available here.
Source: Europa website