Pandemic Special Access Route (PSAR) Interim Authorisation of Lagevrio (Molnupiravir) for COVID-19 Treatment

The Health Sciences Authority (HSA), in consultation with its Medicines Advisory Committee and Panel of Infectious Diseases Experts, would like to update healthcare professionals on the Pandemic Special Access Route (PSAR) interim authorisation of Lagevrio (molnupiravir), the second oral antiviral medicine for COVID-19 treatment.

The PSAR* authorised indication is for the treatment of mild-to-moderate COVID-19 patients aged ≥ 18 years who are at risk of progressing to severe disease and in whom alternative COVID-19 treatment options are not clinically appropriate. The treatment should be administered within 5 days of symptom onset for a duration of 5 days. It is not authorised for the treatment of patients who are already hospitalised due to severe COVID-19.

Lagevrio was observed to have lower efficacy compared to other authorised COVID-19 treatments, and its efficacy and safety in the vaccinated population have not been established. In a subgroup analysis in patients who were sero-positive at baseline in the clinical study, there was a higher proportion of subjects in the treatment arm (3.7%) who had progressed to hospitalisation or death compared to the placebo arm (1.4%), suggesting that there was a lack of efficacy of molnupiravir in the vaccinated population. This is a clinically relevant consideration in Singapore given that most of our population has been fully vaccinated and most would have SARS-CoV-2 antibodies.

The treatment is not recommended for pregnant women, lactating mothers, and those below 18 years old. Women of childbearing potential should use a reliable method of contraception for the duration of treatment and for 4 days after the last dose of Lagevrio. Men with partners of childbearing potential should use reliable contraceptive methods during treatment and for at least 3 months after the last dose of Lagevrio. These recommendations are based on findings from animal studies which showed that Lagevrio may affect foetal growth, bone and cartilage development, and DNA.

Clinicians must carefully assess that the potential benefits outweigh the risks in the patient before initiating Lagevrio treatment. For further details, please refer to the Dear Healthcare Professional Letter and the full prescribing information.

* PSAR: Pandemic Special Access Route https://www.hsa.gov.sg/hsa-psar Published: 19 Apr 2022

Dear Healthcare Professional Letters