DCA approves three Covid-19 treatments including Merck’s antiviral pill

 

The Drug Control Authority (DCA) has approved Merck’s molnupiravir for Covid-19 treatment yesterday, making it the second antiviral pill to be approved in Malaysia for treating the disease.

The DCA previously granted provisional approval for Pfizer’s Paxlovid (a pill containing nirmatrelvir and ritonavir) in March.

Both drugs are meant to be administered during the early phases of a Covid-19 infection to reduce the chance of progressing into severe illness.

For molnupiravir, Health director-general Dr Noor Hisham Abdullah said the drug is provisionally approved for treating mild-to-moderate Covid-19 infections among adults who have at least one risk factor for developing severe symptoms.

The local licence registration holder is Merck Sharp & Dohme (Malaysia) Sdn Bhd, while the factories approved to produce it for Malaysia are Patheon Pharmaceuticals’ facilities in the US and Canada, and MSD’s facilities in Puerto Rico.

The drug is also marketed under the name “Lagevrio”.

Lagevrio pills

Molnupiravir and Paxlovid have been touted by some as “game changers” in the battle against Covid-19 because of their ability to prevent severe disease and the fact that it comes in pills, which made them viable options for home treatment.

An earlier antiviral, remdesivir, needed trained medical staff to administer it through an intravenous tube and evidence of its efficacy has been mixed.

Vaccines are also highly effective in preventing severe Covid-19 cases, but a small percentage of infections still result in hospitalisation or death despite full vaccination.

According to the Health Ministry’s Covid-19 Now website, the prevalence of Covid-19 deaths on March 30 (averaged over seven days) was 0.06 per 100,000 adults who had their boosters, compared to 0.24 among those who were fully vaccinated, and 1.79 for the unvaccinated.

Merck previously released interim data showing that its drug can reduce hospitalisations and death by 50 percent, but later revised it to around 30 percent. Some scientists have also raised safety concerns about the drug, and it is not recommended for pregnant women.

Paxlovid pills

Pfizer had reported that Paxlovid could reduce hospitalisations and death by around 89 percent, but unlike molnupiravir, it is unsuited for patients taking certain medications for other medical conditions.

Arthritis drugs to treat severe Covid

Noor Hisham said the DCA has provisionally approved two drugs already being used to treat arthritis in Malaysia, to also be used to treat later stages of a Covid-19 infection.

He said baricitinib may be used to treat hospitalised individuals who require supplementary oxygen, mechanical ventilation, or extracorporeal membrane oxygenation to breathe. It can be administered to adults as well as children 10 years old and above.

Tocilizumab may be used for hospitalised adults undergoing systemic corticosteroid treatment, who also require supplementary oxygen or mechanical ventilation.

“The three drugs are not meant to replace Covid-19 vaccination, and public health measures especially standard operating procedure (SOP) compliance.

“The Health Ministry wishes to inform that the conditional approval requires information on the quality, safety, and efficacy of the antiviral product to be monitored and assessed continuously by the National Pharmaceutical Regulatory Agency, based on the latest data from time to time.

“This is to ensure the product’s benefits always outweigh its risks,” Noor Hisham added. - Mkini