The Health Sciences Authority (HSA) has granted authorization for the use of molnupiravir as an oral treatment for mild to moderate Covid-19.
The drug is recommended to be administered within five days of the onset of symptoms for a period of five days. It can be used by anyone above 18 with Covid-19 symptoms and is suitable for those at risk of progressing to severe symptoms or hospitalization.
Molnupiravir is the second oral antiviral medication to be authorized under Singapore’s Pandemic Special Access Route, which grants early access to new vaccines, medicines and medical devices during a pandemic.
The drug is manufactured by the pharmaceutical company MSD and MSD will be required to submit updated data from only going clinical studies which will then be reviewed by HSA.
HSA reserves the right to terminate the authorization at any time, for example, if new data suggest that the benefits no longer outweigh the risks of treatment.
HSA’s review of the medicine was based on the clinical data from a combined second and third-phase study of 1,400 participants between the ages of 18 and 19 who had one or more risk factors for their Covid-19 to become severe.
The study showed an efficacy of 30 per cent relative risk reduction. Among those who were administered with molnupiravir, 6.8% had progressed to hospitalization or death, compared to 9.7% of participants who did not.
In a subgroup analysis of those who had the Sar-CoV-2 antibody at baseline, 3.7 per cent of those who took molnupiravir had progressed to hospitalization or death, compared to 1.4 per cent who took the placebo.
“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.”
”While the study results indicate that molnupiravir has lower efficacy compared to other authorized Covid-19 treatments, it may have a place in therapy for patients who are at risk of progressing to severe Covid-19, and in whom current available treatment options are clinically inappropriate,” said HSA.
Dr Aileen Dualan, Asia-Pacific head of medical affairs from MSD said in a press release, “Molnupiravir has shown to be effective against a range of variants, and… as an important treatment option for those who are at high risk for progression to severe disease.”
Molnupiravir is not recommended for use in pregnant women, lactating mothers and those below 18 years old.
HSA also said people should use contraception if they have sex while being treated for Covid-19 and for four days after their last dose because findings from animal studies showed that the drug may affect foetal growth, bone and cartilage development, and DNA of the baby.
Side effects of molnupiravir found in clinical studies include diarrhoea, nausea and dizziness, which were generally mild in intensity, said HSA.
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