COVID-19 Treatment
Medicinal products for the treatment of COVID-19 disease
Approval
Drug therapy for the new indication COVID-19 disease is often based on drugs that are either already in development for other diseases or already approved in other indications. Approval is usually granted in a "centralized procedure" after a successful review by the EMA and licensing by the European Commission in all EU member states.
The EMA publishes an EPAR (European Public Assessment Report) for each centrally approved product.
e.g.: https://www.ema.europa.eu/en/medicines/human/EPAR/veklury
Here is the link to the "EPAR- Product information" with the content:
Annex I - Summary of product characteristics (SmPC)
Annex IIA - Manufacturing-authorisation holder responsible for batch release
Annex IIB - Conditions of the marketing authorisation
Annex IIIA - Labelling
Annex IIIB - Package leaflet
Evusheld (Tixagevimab and Cilgavimab)
Evusheld 150 mg + 150 mg Solution for injection
Active substance: Tixagevimab und Cilgavimab, two monoclonal antibodies.
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/evusheld
Indication: pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
Posology: 150 mg of tixagevimab and 150 mg of cilgavimab, administered as two separate sequential intramuscular injections.
Kineret (Anakinra)
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kineret
Active substance: Anakinra Human, interleukin-1 receptor antagonist (r-metHuIL-1ra).
Indication: Kineret is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (suPAR) ≥ 6 ng/ml (see sections 4.2, 4.4 and 5.1).
The recommended dose of Kineret is 100 mg administered once a day by subcutaneous injection for 10 days. The efficacy of Kineret in children with COVID-19 aged 0 to 18 years has not been established.
Paxlovid (Nirmatrelvir and Ritonavir)
Paxlovid 150 mg and 100 mg film-coated tablets
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/paxlovid
Information from BASG about the extension of shelf life to 18 months (20.10.2022)
Information from BASG about the extension of shelf life to 24 months (01.03.2023)
Active substances: Nirmatrelvir and Ritonavir
The active substance Nirmatrelvir blocks the activity of an enzyme needed by the virus to multiply. Paxlovid also contains a low dose of the medicine Ritonavir, which slows the breakdown of Nirmatrelvir, enabling it to remain longer in the body at levels that affect the multiplication of the virus.
Indication: Paxlovid is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe COVID-19.
Posology: The recommended dosage is 300 mg Nirmatrelvir (two 150 mg tablets) with 100 mg ritonavir (one 100 mg tablet) all taken together orally every 12 hours for 5 days. Paxlovid should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.
Regkirona (Regdanvimab)
Regkirona 60 mg/mL concentrate for solution for infusion.
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/regkirona
Information from BASG about the extension of shelf life to 18 months (12.07.2022)
Information from BASG about the extension of shelf life to 24 months (17.01.2023)
Active substance: Regdanvimab, is a monoclonal antibody, that binds to the receptor binding domain (RBD) of the spike(s) protein of SARS-CoV-2 consequently blocking cellular entry and SARS-CoV-2 infection.
Indication: Regdanvimab is indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
RoActemra (Tocilizumab)
RoActemra 20 mg/mL concentrate for solution for infusion.
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/roactemra
Active substance: Tocilizumab, a monoclonal antibody against the human interleukin-6 (IL-6) receptor.
Indication: RoActemra is indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Ronapreve (Casirivimab und Imdevimab)
Ronapreve 300 mg + 300 mg solution for injection/infusion.
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/ronapreve
Active substance: Casirivimab and Imdevimab, two monoclonal antibodies, have been designed to attach to the spike protein of SARS-CoV-2 at two different sites. When the active substances attach to the spike protein, the virus is unable to enter the body’s cells.
Indication: Ronapreve is indicated for:
- Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
- Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg
Veklury (Remdesivir)
Veklury 100 mg powder for concentrate for solution for infusion.
EPAR Product Information: https://www.ema.europa.eu/en/medicines/human/EPAR/veklury (23.09.2022)
Active substance: Remdesivir, an antiviral substance.
Veklury is indicated for the treatment of coronavirus disease 2019 (COVID-19) in:
- adults and paediatric patients (at least 4 weeks of age and weighing at least 3 kg) with pneumonia requiring supplemental oxygen (low- or high-flow oxygen or other non- invasive ventilation at start of treatment)
- adults and paediatric patients (weighing at least 40 kg) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19
Xevudy (Sotrovimab)
Xevudy 500 mg concentrate for solution for infusion.
EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/xevudy
Information from BASG about the extension of shelf life (02.02.2022)
Active substance: Sotrovimab is a human monoclonal antibody, that binds to a highly conserved epitope on the spike protein receptor binding domain of SARS-CoV-2.
Indication: Xevudy is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19 It is recommended that Xevudy is administered within 5 days of onset of symptoms of COVID-19. The recommended dose is a single 500 mg intravenous infusion.
Article 5(3) opinions:
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) may issue opinions according Article 5(3) of Regulation (EC) No 726/2004 to assist national authorities in making a decision on the possible early use of the medicinal product without a marketing authorization in emergency situations.
Compassionate Use in Austria
Compassionate use is an optional exemption anchored in Article 83 of Regulation 726/2004/EC. In Austria, this provision was incorporated into the Medicines Act by the 2009 amendment and implemented in § 8a.
The compassionate use programs are carried out by the participating companies in cooperation with the Republic of Austria.
General information from the BASG on compassionate use, curative testing and named patient use: as well as the list of all Austria approved compassionate use programs under "Procedures in Austria" can be found here.
Lagevrio (Molnupiravir)
Lagevrio 200 mg capsules for oral use.
Active substance: Molnupiravir
Indication: Lagevrio is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
The recommended dose of Lagevrio is 800 mg (four 200 mg capsules) taken orally every 12 hours for 5 days.
Lagevrio should be administered as soon as possible after a diagnosis of COVID-19 has been made and within 5 days of symptom onset.
The safety and efficacy of Lagevrio in patients below 18 years of age have not yet been established.
EMA issued advice on use of Lagevrio in document „Conditions for Use“.
On Feb. 24, 2023, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) issued a decision recommending rejection of the marketing authorization application for Lagevrio (molnupiravir) for the treatment of COVID-19. The rationale is that, based on the assessment of all data submitted by the company, the clinical benefit of Lagevrio in the treatment of patients with COVID-19 who are not receiving supplemental oxygen and who are at increased risk of developing a severe course of COVID-19 disease could not be established. There was no reduction in the risk of hospitalization or death, nor was there a reduction in the duration of illness or time to recovery.
This also removes the precontition for a continued use of Lagevrio under the Compassionate Use Program in Austria. Thus, the continued use of Lagevrio is now only possible in the so-called "Named Patient Use" according to § 8 para. 1 line 2 of the Austrian Medicines Act, according to which a physician authorized to practice medicine independently in Austria must certify that Lagevrio is urgently needed to avert a life-threatening condition or serious damage to health and that this success cannot be expected to be achieved with an approved and available medicinal product according to the state of scientific knowledge.
How to proceed with already delivered packages of Lagevrio is currently still being clarified, as possible recycling scenarios are to be examined. It is therefore explicitly pointed out that the stocks of the delivered Lagevrio packages must continue to be stored in a compliant manner.
For more information, please visit the EMA website:
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/lagevrio
https://www.ema.europa.eu/en/documents/smop-initial/questions-answers-refusal-marketing-authorisation-lagevrio-molnupiravir_en.pdf
Clinical studies on COVID-19 therapy in Austria
Other therapeutic options are still at the clinical trial stage.
All therapy studies approved in Europe can be searched via the EU Clinical Trials Register.
A search limited to "studies on COVID-19 running in Austria" can be found here.
