By PTI
SINGAPORE: Singapore has approved Pfizer’s Paxlovid as the first oral tablet for the treatment of COVID-19 in adult patients in the country who are at risk of severe disease after health authorities reviewed clinical data for the drug, media reports said on Thursday.
Singapore’s Health Sciences Authority (HSA) said it has reviewed available clinical data for Paxlovid, and found that it could reduce Covid-19 related hospitalisation or death by 88.9 per cent when given within three days from the onset of symptoms.
The efficacy rate was 87.8 per cent when given within five days of symptoms appearing, The Straits Times newspaper reported.
Interim authorisation for the oral drug was granted under the Pandemic Special Access Route (PSAR) on January 31.
“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,” Channel News Asia reported.
The pill should be administered 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.
Paxlovid has been found to reduce the risk of COVID-19-related hospitalisation or deaths by 88.9 per cent when administered within three days of the onset of symptoms, according to HSA’s review of the available clinical data based on rolling submissions of the results from an ongoing Phase II/III study.
When administered within five days of the onset of symptoms, the pill reduces that risk by 87.8 per cent.
The efficacy analysis included patients infected with the Delta variant.
HSA said in vitro data has also shown that Paxlovid is “active” against the prevailing variants of concern, including the Delta and Omicron.
More than 2,000 people aged 18 to 88 years had participated in the randomised, placebo-controlled study.
All participants had mild to moderate COVID-19 symptoms and one or more risk factors for progression to severe COVID-19, the report said, quoting the health authority.
A total of 1,039 participants were given Paxlovid and the rest – 1,046 people – received placebos.
The results showed that 0.8 per cent of patients who received Paxlovid were hospitalised, compared to 6.3 per cent of those who received the placebo.
There were also no deaths in the Paxlovid group, compared to 12 deaths in the placebo group, HSA said.
HSA said the safety data showed that Paxlovid is “well-tolerated”.
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.
Meanwhile, Singapore reported 3,101 new COVID-19 cases on Wednesday, which included 2,919 local and 182 imported infections.
There was one fatality reported, according to the latest infection statistics on the MOH website.
This takes the death toll from coronavirus complications to 859.
As on Wednesday, Singapore has recorded 362,176 COVID-19 cases since the start of the pandemic two years ago.
