Following a careful review in record time, Swissmedic – the Swiss Agency for Therapeutic Products – has decided to allow the temporary distribution of remdesivir. As a result, more COVID-19 patients can now immediately be treated while the authorisation documentation is still under review.
With immediate effect, remdesivir can be used more widely in Switzerland for the treatment of COVID-19 patients
02.07.2020
On 29 June 2020, Swissmedic received an application for the temporary authorisation of remdesivir and initiated a corresponding fast-track procedure. Based on the emergency Ordinance on Measures to Combat the Coronavirus adopted by the Federal Council, and following a benefit-risk assessment on the next day, Swissmedic has officially decided to allow the temporary distribution of remdesivir.
Wider use
Products containing the active substance remdesivir and marketed under the brand name "Veklury" may be used in Swiss hospitals, without authorisation, for the treatment of COVID-19 patients until the official authorisation decision is issued or the corresponding emergency status is revoked.
Treating physicians will therefore have immediate access to additional treatment options for patients suffering from SARS-CoV-2-related pneumonia who also require oxygen. The product will also be made available to patients outside approved clinical trials and the approved compassionate use programme while the submitted authorisation application is being reviewed. Adverse reactions to the drug will be closely monitored in order to ensure patient safety.
Scrupulous risk analysis
The Swissmedic experts based their decision on the existing data on quality and manufacturing, non-clinical (preclinical) safety tests, clinical trial data and supplementary safety information obtained from the use of remdesivir in the compassionate use programmes. A broad-based clinical trial with the active substance remdesivir in the USA found that the benefit-risk profile was positive in COVID-19 patients with pneumonia and requiring additional oxygen. The hospital stay was shortened in almost a third of the test subjects.
The rapid decision to approve remdesivir while the authorisation procedure was still under way was made possible thanks only to the cooperation with other federal agencies and preliminary talks with the applicant.
Swissmedic processes all applications relating to the COVID-19 pandemic with the appropriate priority and urgency.
Indication
The use of remdesivir (Veklury) is indicated for the treatment of coronavirus disease (COVID-19) in adults and young people aged 12 years and over who are suffering from SARS-CoV-2-related pneumonia and who also require oxygen.
Temporary authorisation
Applicants can submit an application for temporary authorisation according to Art. 9 of the Therapeutic Products Act (TPA) even before drug development is fully completed. This allows the Swissmedic experts to start reviewing the available data while, for example, further clinical trials whose results are to be submitted at a later date are still in progress.
Benefit-risk evaluation
A product can be authorised if the application documentation indicates that the expected benefit outweighs the potential risks (positive benefit-risk evaluation). Swissmedic thereby ensures that only high-quality, safe and effective medicines are placed on the market in Switzerland.
Compassionate use
Compassionate use refers to the use of medicines that have not (yet) been authorised in seriously ill patients who cannot be treated satisfactorily with authorised medicines.
Procurement and supply
The next steps, for which the Federal Office of Public Health and the Armed Forces Pharmacy are responsible, are to procure remdesivir and establish its price.