COVID-19 – Indonesia issues EUA for Paxlovid as medicine

“The recommended dose is 300 mg Nirmatrelvir (two 150 mg tablets) with 100 mg Ritonavir (one 100 mg tablet) taken together twice a day for five days.”

 

Jakarta (Indonesia Window) – The Indonesian National Agency of Drug and Food Control (BPOM) has officially issued an Emergency Use Authorization (EUA) for the film-coated tablet Paxlovid as a COVID-19 medicine in the country.

“The approved Paxlovid is a film-coated tablet in the form of a combipak, consisting of Nirmatrelvir 150 mg and Ritonavir 100 mg with an indication for treating COVID-19 in adults who do not require supplemental oxygen and who are at high risk of progression to severe COVID-19,” the head of Indonesia’s BPOM, Penny K. Lukito, said in a written statement on Monday.

The addition of this type of antivirus for handling COVID-19, which received the EUA, became one of the alternatives for managing COVID-19 in Indonesia, Penny explained.

“The recommended dose is 300 mg Nirmatrelvir (two 150 mg tablets) with 100 mg Ritonavir (one 100 mg tablet) taken together twice a day for five days,” she said, adding that Paxlovid, which is a SARS-CoV-2 protease inhibitor antiviral therapy, is developed and manufactured by Pfizer.

Based on the results of studies related to its safety, in general the administration of Paxlovid is safe and tolerable.

The most frequently reported mild to moderate adverse events in the group receiving the drug were dysgeusia (5.6 percent), diarrhea (3.1 percent), headache (1.4 percent), and vomiting (1, 1 percent) with a higher incidence than the placebo group (0.3 percent; 1.6 percent; 1.3 percent; and 0.8 percent, respectively).

In terms of efficacy, the results of phase 2 and 3 clinical trials show that Paxlovid can reduce the risk of hospitalization or death by 89 percent in adult COVID-19 patients who are not hospitalized with comorbidities, so they are at risk of developing severe disease.

Comorbidities associated with this increased risks include elderly, obesity, active smoking, history of heart disease, diabetes, or kidney disorders.

The head of the BPOM appreciates the contribution and support from various related parties, namely the Expert Team of the National Committee for Drug Evaluation and the association of clinicians that have studied intensively until the EUA of the film-coated tablet Paxlovid is approved.

Furthermore, the agency together with the Ministry of Health will continue to monitor the safety of using Paxlovid in Indonesia, she said.

The BPOM also supervises the supply chain of Paxlovid so that the safety, efficacy and quality of the circulating drugs can be maintained, and prevent their illegal use.

Previously, the BPOM issued EUAs for antivirals Favipiravir and Remdesivir (2020), monoclonal antibody Regdanvimab (2021), and Molnupiravir (2022).

The addition of an additional type of antivirus for handling COVID-19 that received the EUA has become one of the alternatives for managing COVID-19 in Indonesia.

Reporting by Indonesia Window