SINGAPORE: Pfizer's Paxlovid has become the first oral tablet approved in Singapore for the treatment of COVID-19 in adult patients who are at risk of severe disease.
Interim authorisation for the oral medicine was granted under the Pandemic Special Access Route (PSAR) on Jan 31, the Health Sciences Authority (HSA) said on Thursday (Feb 3).
"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 severe disease, to reduce the risk of hospitalisation and death," added the authority.
The pill should be taken twice a day for five days, HSA said, with treatment being initiated "as soon as possible after a diagnosis has been made, within five days of the onset of COVID-19 symptoms".
HSA added that the pill will be prescribed and prioritised to those at higher risk of severe COVID-19 illness, as directed by the Ministry of Health (MOH).
Paxlovid has been found to reduce the risk of COVID-19 related hospitalisation or death by 88.9 per cent when treatment was given within three days of onset of symptoms, according to HSA's review of the available clinical data.
When given within five days of onset of symptoms, the pill reduces that risk by 87.8 per cent.
HSA said the safety data showed that Paxlovid is "well-tolerated".
"The incidences of adverse events reported in the clinical study were generally low. The common adverse events reported were mild to moderate, such as altered sense of taste, diarrhoea, vomiting, hypertension, muscle pain (myalgia) and chills."
The pill may interact with various medications, such as medicines for irregular heart rate, migraine, and cholesterol, said HSA, adding that it could increase the amount of these medications in the blood, leading to "serious adverse events".
"On the other hand, some medicines such as those for epileptic seizures could reduce the levels of Paxlovid resulting in a loss of anti-viral efficacy. The potential for drug interactions should be carefully considered by the prescribing doctor prior to treatment initiation."
Based on the available clinical evidence, HSA said the benefits of Paxlovid outweigh the risks, and there is a "favourable benefit-risk profile" for the treatment of mild to moderate COVID-19 in adults who are at high risk of progression to severe COVID-19.
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Interim authorisation for the oral medicine was granted under the Pandemic Special Access Route (PSAR) on Jan 31, the Health Sciences Authority (HSA) said on Thursday (Feb 3).
"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 severe disease, to reduce the risk of hospitalisation and death," added the authority.
The pill should be taken twice a day for five days, HSA said, with treatment being initiated "as soon as possible after a diagnosis has been made, within five days of the onset of COVID-19 symptoms".
HSA added that the pill will be prescribed and prioritised to those at higher risk of severe COVID-19 illness, as directed by the Ministry of Health (MOH).
Paxlovid has been found to reduce the risk of COVID-19 related hospitalisation or death by 88.9 per cent when treatment was given within three days of onset of symptoms, according to HSA's review of the available clinical data.
When given within five days of onset of symptoms, the pill reduces that risk by 87.8 per cent.
HSA said the safety data showed that Paxlovid is "well-tolerated".
"The incidences of adverse events reported in the clinical study were generally low. The common adverse events reported were mild to moderate, such as altered sense of taste, diarrhoea, vomiting, hypertension, muscle pain (myalgia) and chills."
The pill may interact with various medications, such as medicines for irregular heart rate, migraine, and cholesterol, said HSA, adding that it could increase the amount of these medications in the blood, leading to "serious adverse events".
"On the other hand, some medicines such as those for epileptic seizures could reduce the levels of Paxlovid resulting in a loss of anti-viral efficacy. The potential for drug interactions should be carefully considered by the prescribing doctor prior to treatment initiation."
Based on the available clinical evidence, HSA said the benefits of Paxlovid outweigh the risks, and there is a "favourable benefit-risk profile" for the treatment of mild to moderate COVID-19 in adults who are at high risk of progression to severe COVID-19.
Continue reading...