Swissmedic has approved the medicinal product Ronapreve, which was already authorised for prescription in Switzerland under COVID-19 Ordinance 3.
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Ronapreve is an antibody combination that can be used for treatment or prevention of coronavirus disease.
Swissmedic approved Ronapreve solution for injection/infusion on 23rd December 2021. Ronapreve is indicated in adults and adolescents aged 12 years or older with a bodyweight of at least 40 kg:
• for treatment of COVID-19 if oxygen therapy or hospitalisation is not required and there is a high risk of developing a severe form of COVID-19.
• for prevention of COVID-19 when an adequate immune response to COVID-19 vaccination is not possible.
The product comprises a combination of the antibodies casirivimab and imdevimab. The medicinal product is administered intravenously or subcutaneously (injection under the skin). Preparation and administration should be initiated and monitored by a qualified healthcare professional.
Ronapreve is the first medicinal product approved in Switzerland that can be used to prevent COVID-19 in individuals who cannot mount an adequate immune response to COVID-19 vaccination due to other diseases or treatments.
Swissmedic reviewed the application for authorisation from 5 March 2021 onwards in a rolling submission. This involves continual collection and submission to Swissmedic of the data required. Use of the antibody medication in Switzerland has been permitted since 15 April 2021 based on the exceptions in COVID-19 Ordinance 3.
In this procedure, no data on efficacy against the Omicron variant were submitted.
This week, Janssen-Cilag AG submitted data on the booster dose of its "COVID-19 Vaccine Janssen" to Swissmedic. The Agency has approved the authorisation application, which means that persons aged 18 years and older can now receive a booster dose after a first vaccination.
On 22 March 2021, Swissmedic authorised "COVID-19 Vaccine Janssen" from Janssen-Cilag AG. This vector-based vaccine is administered as a single dose to persons aged 18 and older.
At the request of the applicant, Johnson & Johnson, Swissmedic has reviewed and approved the clinical data on safety and efficacy submitted for the booster. The second dose of the vaccine can be administered, at the earliest, two months after the first dose.
The authorisation application also included clinical data on mixed vaccinations. Johnson & Johnson combined the mRNA vaccines from Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) with its own vaccine.
For a mixed vaccination, Swissmedic approved an interval for the booster dose of six months after the second mRNA vaccination. This period is the same as that for a booster with mRNA vaccines. This is the first time in Switzerland that an applicant has submitted clinical data on a mixed vaccination. ■