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Jakarta Post

BPOM approves emergency use of antiviral drugs to treat COVID-19 patients

  • News Desk

    The Jakarta Post

Jakarta   /   Tue, October 6, 2020   /   12:38 pm
BPOM approves emergency use of antiviral drugs to treat COVID-19 patients A lab technician holds tablets of the COVID-19 drug favipiravir at Eva Pharma facility in Cairo on June 25. (Reuters/Amr Abdallah Dalsh)

The Food and Drug Monitoring Agency (BPOM) has issued emergency use authorization (EUA) for two antiviral drugs, favipiravir and remdesivir, to treat COVID-19 patients.

The BPOM also granted permits in September to several pharmaceutical companies to produce the drugs. PT Beta Pharmacon (Dexa Group) received a permit to produce favipiravir, locally sold under the Avigan brand. State-owned drug manufacturer PT Kimia Farma received the permit to produce a generic favipiravir product, tempo.co reported on Wednesday.

Meanwhile, permits to produce remdesivir have been granted to PT Amarox Pharma Global, which is a subsidiary of India's leading generic drug maker Hetero, as well as to state-owned pharmaceutical firm PT Indofarma and local private firm PT Dexa Medica.

Data from the Office of the Coordinating Maritime Affairs and Investment Minister show that the government had previously given contractors the go-ahead to import COVID-19 medication such as remdesivir, favipiravir, oseltamivir and lopinavir-ritonavir, all of which will be distributed directly to hospitals treating coronavirus patients.

The data show that, by the end of 2020, the government expects to secure 670,000 vials of remdesivir from foreign sources, but it also expects the drug to be manufactured in the country starting in November.

In late September, Reuters reported that a late-stage study by Fujifilm Holdings Corps of its antiviral drug Avigan showed that it reduced recovery times for COVID-19 patients with nonsevere symptoms.

The Phase 3 clinical study of 156 patients in Japan showed that those treated with Avigan improved after 11.9 days, versus 14.7 days for a placebo group.

Meanwhile drugmaker Gilead Sciences said in a statement that a five-day course of the remdesivir sped up recovery in moderately ill patients with pneumonia from COVID-19. The drug has reportedly been administered to United States President Donald Trump, who was announced COVID-19 positive last Friday.

BPOM head Penny K Lukito expects that they EUA issuance will help accelerate access to those drugs for hospitals treating COVID-19 patients.

“Hopefully, the drugs will help improve COVID-19 recovery rates and bring down the mortality rate from the pandemic,” Penny said in a statement on Tuesday.

She said she hoped doctors and health workers would cooperate in monitoring the efficacy and safety of those drugs under pharmacovigilance.

The World Health Organization defines pharmacovigilance (PV) as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.

All pharmacovigilance reports will be received by the BPOM and evaluated periodically.

If there is an increasing trend of side effect, the BPOM will immediately communicate the risk and revoke the EUA, the statement further said.

Since March, the BPOM periodically searches the internet to detect any disinformation regarding drugs claimed to cure COVID-19. It had found more than 46,000 links, including 2,645 links of people illegally selling what they claim are COVID-19 drugs.

Upon such findings, the BPOM recommends that the Indonesian E-Commerce Association (IDEA) and Communications and Information Ministry take down those links. (iwa)

 

Editor’s note: This article is part of a public campaign by the COVID-19 task force (Satgas COVID-19) to raise people’s awareness about the pandemic.