Statement on Ronapreve™

Roche Products (India) Pvt. Ltd. along with its distribution partner Cipla Ltd., would like to update the following in relation to the use of RonapreveTM (Casirivimab 120mg/ml and Imdevimab 120 mg/ml Solution Injection for intravenous infusion or subcutaneous administration) in India:

• Similar to several other antibody treatments, Ronapreve does not retain efficacy against the Omicron variant. There is no data on the clinical use of RonapreveTM in patients infected with the Omicron variant. However, Ronapreve remains highly effective against all other key circulating variants including Delta and Delta Plus, and it would be key for patients with these other variants to have access to this treatment;

• Decisions regarding the use of RonapreveTM for treatment or prophylaxis should take into consideration what is known about the characteristics of the circulating SARS-CoV-2 viruses including regional or geographical differences and available information on RonapreveTM susceptibility patterns. Whenever possible, monitoring the regional Omicron prevalence and identifying non-Omicron patients via diagnostic tests is the best way to ensure eligible patients will benefit from Ronapreve..

• When molecular testing or sequencing data is available (which will indicate the variant), it should be considered when selecting antiviral therapy to rule out SARs-CoV-2 variants that are shown to have reduced susceptibility to RonapreveTM.

Accordingly, the following guidelines are provided, given the prevalence of the Omicron variant in India:

1. Treatment in mild to moderate COVID-19 patients:

• Use according to Emergency Use Authorisation (EUA)

• AND if molecular testing or sequencing data show that the infection is not due to the Omicron variant

• OR as per state guidelines according to local relative prevalence of the Omicron / Delta VoCs ;

2. Post-exposure prophylaxis

• Use according to EUA

• AND if molecular testing or sequencing data show that the infection of the index case was not due the Omicron variant

• OR as per state guidelines according to local relative prevalence of the Omicron / Delta VOCs

As per the current Emergency Use Authorization of RonapreveTM in India, it should not be used in patients who are hospitalised due to Covid-19, OR require oxygen therapy due to COVID-19, OR require an increase in baseline oxygen flow rate due to Covid-19 in those on chronic oxygen therapy due to underlying non-Covid-19 related comorbidity.

Health Care Professionals (HCPs) are advised to refer to the complete prescribing information for the instructions on preparation of solution and administration of RonapreveTM.

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