KUALA LUMPUR: The Health Ministry has given conditional registration approval for Pfizer's Covid-19 drug Paxlovid to treat adults infected with the virus.
This is the first oral pill specifically developed to treat the illness approved in Malaysia.
Health director-general Tan Sri Dr Noor Hisham Abdullah said this was decided during the 370th Drug Control Authority meeting today.
Paxlovid, he said, would be indicated for the treatment of Covid-19 in adults aged 18 and above who do not require supplemental oxygen and who are at increased risk for progressing to severe Covid-19.
Dr Noor Hisham said Paxlovid, however, was not intended to be used as a replacement for Covid-19 vaccinations and public health measures particularly standard operating procedures (SOP) compliance.
"The Health Ministry would like to inform that this conditional registration approval requires information on the quality, safety and effectiveness of antivirus products to be monitored and evaluated continuously by the National Pharmaceutical Regulatory Division (NPRA), based on the latest data from time to time.
"It is to ensure that the comparison of benefit over risk for the product remains positive.
"The Health Ministry will continue improving the people's access to medicines for the treatment or prevention of Covid-19 transmission in Malaysia, by ensuring that they are properly evaluated based on quality, safety and effectiveness," he said in a statement today.
Paxlovid is a combination product containing two different tablets of antiviral medicines: ritonavir and an investigational compound called PF-07321332. One dose of Paxlovid consists of two pink tablets and one white tablet taken together at the same time.
Paxlovid should be administered as soon as possible after a diagnosis of Covid-19 has been made and within five days of symptom onset.
Pfizer's clinical trials have shown that Paxlovid may reduce the risk of needing hospital admission or dying from Covid-19 disease by up to 89 per cent compared to placebo in non-hospitalised high-risk adults with Covid-19.
In the overall population study, no deaths were reported in patients who received Paxlovid as compared to 10 deaths in patients who received placebo.
According to Pfizer's "Fact Sheet for Patients, Parents, and Caregivers", possible side effects of Paxlovid are allergic reactions, liver problem, resistance to HIV medicines, altered sense of taste, diarrhea, high blood pressure or muscle aches.
"Allergic reactions can happen in people taking Paxlovid, even after only one dose. Stop taking Paxlovid and call your healthcare provider right away if you get any of the following allergic reaction symptoms— hives, trouble swallowing or breathing, swelling of the mouth, lips, or face or throat tightness, hoarseness and skin rash."