May 11, 2022

Singapore approves Pfizer’s Covid-19 pill, Paxlovid; serious side effects possible if taken with other drugs, Singapore News

SINGAPORE – A new oral antiviral drug for the treatment of Covid-19 has been approved for use in Singapore, the Health Sciences Authority announced on Thursday (February 3rd).

“This is the first oral tablet approved in Singapore for the treatment of mild to moderate Covid-19 in adult patients who are at high risk of progression to serious disease, to reduce the risk of hospitalization and death” , he added.

Pfizer’s drug, Paxlovid, was granted interim clearance under the HSA’s Pandemic Special Access Route (PSAR) on Jan. 31.

The authority approved the drug in consultation with its drug advisory committee.

The drug should be taken twice a day for five days and should be administered as soon as possible within five days of the onset of symptoms of Covid-19.

The HSA said those most at risk of serious illness from Covid-19 will be given priority for the drug.

The authority said it reviewed available clinical data for the drug and found it could reduce Covid-19-related hospitalizations or deaths by 88.9% when given within three days of onset. symptoms.

The efficacy rate was 87.8% when given within five days of the onset of symptoms.

This analysis included patients infected with the Delta variant, and laboratory studies have shown that the drug works against the dominant variants of concern, including the Delta and Omicron variants.

Paxlovid is a combination of two drugs – nirmatrelvir, an antiviral drug, and ritonavir, which helps keep nirmatrelvir active in the body in higher concentrations for longer to fight off the virus.

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Pfizer Singapore on Thursday announced an agreement with Singapore to supply Paxlovid here.

He said in a statement that nirmatrelvir was specifically designed to block the activity of the Sars-CoV-2 3CL enzyme, which the coronavirus needs to replicate.

Pfizer Singapore Country Director Erika Pagani said oral treatments help reduce the severity or onset of illness in patients with Covid-19, and therefore could be an important tool in coping with the global impact of the pandemic.

HSA noted that there were generally a low number of cases with side effects in the clinical study.

Common side effects reported were mild to moderate, such as altered taste, diarrhea, vomiting, high blood pressure, muscle aches and chills, he added.

The authority stated that Paxlovid can also interact with various medications such as irregular heartbeat, migraine, and cholesterol medications leading to serious side effects.

Certain medications, such as drugs for seizures, could lower the level of Paxlovid and reduce antiviral effectiveness, HSA said, urging doctors prescribing Paxlovid to carefully consider the potential for drug interactions.

Pfizer is required to collect relevant safety data and monitor the use of its medicine as a condition of provisional authorization under the PSAR.

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HSA will also ask Pfizer to continue to submit updated data from ongoing clinical studies to ensure the continued safety and efficacy of Paxlovid, such as its effectiveness against the predominant variants.

Countries including South Korea, Britain and Israel began administering Paxlovid to coronavirus patients from this month.

To ensure poorer countries can use the drug, Pfizer has agreed to allow generic manufacturers to supply versions of Paxlovid to 95 low- and middle-income countries through a licensing agreement with the international group. Public Health Medicines Patent Pool.

HSA is currently reviewing molnupiravir, another antiviral pill.

Clinical trials have shown that it can halve the likelihood of dying or being hospitalized, for people at risk of serious illness.

Paxlovid and molnupiravir have both been approved by the United States Food and Drug Administration.

Dr Shawn Vasoo, clinical director of the National Center for Infectious Diseases, previously told the Straits Times that doctors will need to assess their patients’ medical histories to assess their suitability for Covid-19 treatments.

“Vaccination remains the mainstay of prevention, and the vast majority (who are infected) will be fine and will not require any specific treatment if they have no risk factors for serious disease,” he said.

This article was first published in The time of the straits. Permission required for reproduction.


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