Jakarta (Indonesia Window) – Indonesia’s National Agency of Drug and Food Control (BPOM) has issued an emergency use authorization (EUA) for the COVID-19 antiviral drug Molnupiravir.
“After going through an evaluation of clinical trial data together with an expert team of the National Committee for Drug Assessment and clinical associations for the EUA approval, BPOM and the Health Ministry continue to monitor the safety of the use of Molnupiravir in Indonesia,” BPOM’s head Penny K Lukito said in a press release received here on Friday (Jan. 14).
Penny added that the approved Molnupiravir is in 200 mg capsule registered by Indonesia’s Amarox Pharma Global company and manufactured by Hetero Labs Ltd., India.
The drug is indicated for the treatment of mild to moderate COVID-19 infections for patients aged 18 years old and over who do not require oxygen equipment and have an increased risk of developing severe COVID-19 infection.
“The drug is given twice a day of four capsules of 200 mg each for five days,” Penny explained.
Earlier, BPOM had issued EUA for several COVID-19 antivirus drugs including Favipiravir, Remdesivir, Regdanvimab monoclonal antibody, and Molnupiravir.
Molnupiravir was developed by Merck Sharp & Dohme (MSD). Meanwhile, MSD has granted voluntary licensing (VL) to several manufacturers in India, one of which is Hetero Labs Ltd. to meet global supply needs quickly while paying attention to quality and providing choices at competitive prices.
Penny said, the evaluation results on the safety aspect showed that giving Molnupiravir was relatively safe and had tolerable side effects. The most commonly reported side effects are nausea, headache, drowsiness, as well as abdominal and oropharyngeal pains.
In addition, the results of non-clinical and clinical trials show that Molnupiravir does not cause liver dysfunction.
However, Molnupiravir should not be used by pregnant women, and women of childbearing age who are not pregnant should use contraception while taking Molnupiravir.
According to Penny, the results of the third phase of clinical trials show that Molnupiravir could reduce the risk of hospitalization and even death by 30 percent in mild to moderate COVID-19 patients and 24.9 percent in mild COVID-19 patients.
To support the availability of COVID-19 drugs in Indonesia, Amarox Pharma Global is preparing for local production of Molnupiravir capsules through technology transfer at the Amarox Cikarang production facility in Bekasi district, West Java province.
“A letter of approval for the use of the non-betalactam capsule production facility was issued on January 3, 2022, and after the requirements for Good Manufacturing Practices of Drugs can be met by the industry, local production is ready in early March 2022. This joint effort aims at supporting the independence of the national drug industry,” the head of BPOM said.
The agency also supervises the production and distribution chain of drugs to maintain the safety, efficacy and quality of circulating drugs, while preventing the use of illegal drugs.
Reporting by Indonesia Window