BPOM approves COVID-19 drug Avifavir for emergency use

BPOM approves COVID-19 drug Avifavir for emergency use

A screenshot of the emergency-use permit (EUA) for corona drug Avifavir, which has been officially cleared by the Indonesian Food and Drug Supervisory Agency (BPOM). (ANTARA/Andi Firdaus)

Jakarta (ANTARA) - Indonesia’s Food and Drug Monitoring Agency (BPOM) has approved COVID-19 drug Avifavir for emergency use on coronavirus patients.

"It's true that BPOM has issued EUA for the product in question," BPOM spokesperson for COVID-19 vaccinations, Lucia Riski Andalusia, confirmed via text here on Thursday afternoon.

Avifavir obtained emergency license number EUA2158200117A1 from BPOM on March 17, 2021, she informed.

In a written statement, BPOM said Avifavir claims to kill the virus within an average duration of four days under standard care. Meanwhile, the new variant of the virus can be paralyzed within nine days, the drug’s developers have claimed, BPOM added.

In addition, the BPOM stated, the drug's efficacy has been shown to be more than 80 percent. The clinical study results also show that the drug can be safely consumed by all age groups, it said.

Related news: BPOM encourages self-reliance in human cell-based drug production

Avifavir is claimed to be the first Russian-manufactured drug that has been approved to treat coronavirus infections. It is also the first favipiravir-based drug in the world to be approved for the treatment of COVID-19, BPOM said.

In its statement, BPOM informed that since the beginning of June, 2020, Avifavir has been supplied to all regions of Russia and 15 countries around the world. Indonesia has been the first Asian country to register for the drug.

A press release from the Russian Direct Investment Fund (RDIF) stated that Avifavir has been registered in Indonesia under an expedited procedure, based on data obtained during the second and third phase clinical trials.

According to the RDIF report, the trial involved 460 patients and was conducted according to good clinical practices (GCP), a quality standard for international clinical trials involving human subjects, from April to September, 2020 at 30 special facilities across Russia.

Based on the research results, Avifavir has shown high efficacy in the treatment of patients infected with the coronavirus, it said.  

 

Related news: BPOM: Temperature key to maintaining COVID-19 vaccine quality

 

 

Comments