Critical Review and Analysis of Approval of Favipiravir for Restricted Emergency Use in Mild to Moderate COVID-19

18 Pages Posted: 7 Jul 2020

See all articles by Arunkumar Radhakrishnan

Arunkumar Radhakrishnan

Chettinad Hospital and Research Institute

Ruckmani Arunachalam

Chettinad Hospital and Research Institute

Abinaya Elango

Chettinad Hospital and Research Institute

Date Written: June 27, 2020

Abstract

Central Drugs Standard Control Organization (CDSCO), the Indian drug regulatory agency, granted accelerated approval to Glenmark Pharmaceuticals to market Favipiravir in mild to moderate COVID-19 on 19/06/2020, for restricted use. The patients should sign informed consent before receiving Favipiravir. Subsequently, Glenmark Pharmaceuticals issued a press release on 20/06/2020 stating that it was a landmark development for COVID-19 patients in India and the approval was backed by strong clinical evidence supporting the use Favipiravir in COVID-19.

The authors carefully reviewed the press release issued by Glenmark Pharmaceuticals, product information and informed consent form available with Fabiflu® (Glenmark’s Favipiravir brand) and public notice issued by the Drugs Controller General of India. They have gone through the legal aspects of emergency approvals in India and USA, WHO’s clinical trial synopsis for assessing efficacy of anti-COVID drugs and emergency use authorization granted to Remdesivir in USA. They critically analyzed the efficacy data presented in favor of Favipiravir in this due process.

Based on the review and analysis, the authors consider that the two crucial publications quoted in the product information, Chang C et al (2020) and Cai Q et al (2020), do not provide convincing evidence for efficacy of Favipiravir. The entire clinical data presented in the press release and product information do not offer undisputed support for the efficacy of Favipiravir in mild to moderate COVID-19. Moreover, it is the right time to take policy decision and frame guidelines on how to handle emergency approvals for medicinal products in grave situations like COVID-19 pandemic, in India.

Note: Conflict of Interest: The authors declare that they have no conflict of interest in writing this manuscript.

Funding: None to declare

Keywords: COVID-19, Fabiflu, Favipiravir, Glenmark

Suggested Citation

Radhakrishnan, Arunkumar and Arunachalam, Ruckmani and Elango, Abinaya, Critical Review and Analysis of Approval of Favipiravir for Restricted Emergency Use in Mild to Moderate COVID-19 (June 27, 2020). Available at SSRN: https://ssrn.com/abstract=3636958 or http://dx.doi.org/10.2139/ssrn.3636958

Arunkumar Radhakrishnan (Contact Author)

Chettinad Hospital and Research Institute ( email )

Rajiv Gandhi Salai
Kelambakkam
Chengalpattu, TN Tamilnadu 603103
India
603103 (Fax)

Ruckmani Arunachalam

Chettinad Hospital and Research Institute ( email )

Rajiv Gandhi Salai
Kelambakkam
Chengalpattu, TN Tamilnadu 603103
India
603103 (Fax)

Abinaya Elango

Chettinad Hospital and Research Institute ( email )

Rajiv Gandhi Salai
Kelambakkam
Chengalpattu, TN Tamilnadu 603103
India
603103 (Fax)

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