MSD (Merck in North America) has achieved temporary approval under the Pandemic Special Access Route (PSAR) of the Singapore Health Sciences Authority (HSA) for its antiviral drug Lagevrio (molnupiravir) for the treatment of Covid-19.
Lagevrio is the second oral antiviral treatment that is licensed in the region to treat mild to moderate Covid-19 in people aged 18 years and older.
It is intended for patients who are at risk for disease progression to severe Covid-19 and / or hospitalization, and for those who do not have clinically appropriate replacement therapy for Covid-19.
According to the HSA approval, Lagevrio is indicated to be given within five days after symptom development for five days after discussion with its advisory medical committee.
According to the guidelines of the Ministry of Health, the antiviral drug will be prescribed to individuals who are at increased risk of severe Covid-19, on a priority basis.
The regulatory agency’s review was based on clinical results from a Phase II / III trial analyzing Lagevrio’s ability to lower hospitalization or mortality risk in mild to moderate Covid-19 patients.
According to the experimental data, treatment with Lagevrio resulted in a relative risk reduction of 30% compared to placebo.
Furthermore, the rates of progression to hospitalization or death were 6.8% and 9.7% in the Lagevrio and placebo arms, respectively.
The data obtained to date showed that 48 admissions and two deaths were reported in the Lagevrio arm, while 68 admissions and 12 deaths were observed in the placebo arm.
Diarrhea, nausea and dizziness of mild severity were the common side effects associated with Lagevrio reported in the clinical trials.
In December last year was The US Food and Drug Administration has granted an emergency use permit for molnupiravir for the treatment of adults with mild to moderate Covid-19.