Epidemiological Data And Recommendation From WHO Are The Reason For The Food and Drug Supervisory Agency Approves Clinical Trials Of Ivermectin As A COVID-19 Drug

ILLUSTRATION/BETWEEN

JAKARTA - The Food and Drug Supervisory Agency (BPOM) has issued an Approval for the Implementation of Clinical Trials (PPUK) for the drug Ivermectin.

This decision was conveyed by the Head of BPOM Penny Lukito accompanied by the Minister of State-Owned Enterprises (BUMN) Erick Thohir.

Penny said that BPOM had issued a license to use or distribute a drug under the brand name Ivermectin for worm infection indications given in certain doses. Because this drug is included in the hard drug class.

"Ivermectin is a strong drug that must be prescribed by a doctor. However, epidemiological data and global publications have stated that Ivermectin can also be used to treat COVID-19", said Penny in a press conference broadcast online on BPOM's YouTube channel, Monday, June 28.

In addition, this approval was also given after a recommendation from the World Health Organization (WHO). In the recommendation mentioned Ivermectin can be used in the framework of clinical trials.

Not only WHO but similar recommendations were also issued by the US Food and Drugs Administration (FDA) and the European Medicines Agency (EMA).

"However, we still have to collect clinical trial data, which is currently not conclusive if it is used for COVID-19", said Penny.

"For this reason, the BPOM is in line with WHO recommendations to facilitate the implementation of clinical trials initiated by the Health Research and Development Agency (Balitbangkes) of the Ministry of Health", she added.

This test was carried out by giving Ivermectin for five days to COVID-19 patients and then observing it for 28 days. The clinical trial will last for approximately three months with the provision of reports every month.

Meanwhile, the location of the Ivermectin clinical trial will be carried out in eight hospitals, namely Persahabatan Hospital Jakarta, Sulianti Saroso Hospital Jakarta, Dr. Soedarso Pontianak, Adam Malik General Hospital in Medan, and Gatot Subroto Army Hospital in Jakarta.

In addition, Dr. Esnawan Antariksa Hospital Jakarta, Dr. Suyoto Hospital Jakarta, and the COVID-19 Emergency Hospital Wisma Atlet Kemayoran Jakarta. "However, if the community needs this drug, doctors can give the drug by observing the clinical trial protocol", concluded Penny.