The Drug Controller General of India (DCGI) has recently given approval to Indian pharma companies Glenmark and Strides Pharma Science to initiate clinical trials of favipiravir for COVID-19 patients. The lack of definitive treatment for COVID-19 has paved the way for repurposing the existing drugs for COVID-19 treatment and Indian pharma companies also want to leverage this opportunity, says GlobalData, a data and analytics company.
Favipiravir, a broad-spectrum antiviral drug, approved for flu in Japan in 2014, is undergoing clinical trials for COVID-19 in various countries such as China, Japan, the US, Russia, Italy and South Korea. The drug was also used as emergency treatment during an Ebola virus outbreak.
Favipiravir had shown positive results in early clinical trials conducted in China in COVID-19 patients with mild to moderate symptoms. However, the recent interim data published from trials in Japan indicated that the drug is not effective in controlling the progression of the disease. Additionally, it has been observed that favipiravir may induce teratogenic effects. However, the drug is still being pushed by the Japanese government.
According to the GlobalData’s COVID-19 dashboard, as of 1 June 2020, India has 191,041 confirmed cases and forecasts 723,837 confirmed cases in India in a low transmission risk scenario by 14 June 2020.
Nag Madhavi, Pharma Analyst at GlobalData, says, “Companies like Glenmark and Strides should not be highly optimistic at this point of time considering the facts that the government of India is not satisfied with the efficacy and interim results of favipiravir. Earlier, the Task Force for Repurposing of Drugs (TFORD) has recommended favipiravir as a promising drug candidate for COVID-19 treatment.”
The repurposing of existing drugs is indeed an effective strategy for the treatment of COVID-19 as these drugs would require less clinical development time and the majority of the repurposed drugs are available as generics making them affordable compared to novel drugs. Some of the drugs which are being repurposed in India are hydroxychloroquine, remdesivir, sepsivac, ritonavir/lopinavir combination, ivermectin, Interferon alfa-2b, tocilizumab and itolizumab.
Madhavi concludes, “The interim results of favipiravir in Japan were not so encouraging. Hence, it is hard to predict the outcomes of favipiravir trials in India. Even if favipiravir is approved and reaches the market then it will have to face competition from other repurposed drugs as the research and development landscape for COVID-19 treatment is evolving at a rapid pace.”