CDSCO Ends Emergency-Use Authorization of Baricitinib for COVID-19 Treatment

New Delhi: In a recent regulatory update, the Central Drugs Standard Control Organisation (CDSCO) has formally approved the withdrawal of COVID-19 treatment indications, originally granted for restricted emergency use, for Baricitinib Tablets 2 mg and 4 mg, following a request from Eli Lilly and Company (India).

The withdrawal specifically affects the emergency-use authorizations that allowed Baricitinib, either alone or in combination with Remdesivir, to treat hospitalized COVID-19 patients requiring supplemental oxygen, invasive or non-invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). These authorizations had been issued in May 2021 and November 2021, respectively.

Despite this change, Baricitinib tablets will continue to be marketed and prescribed for their approved indication in the treatment of Rheumatoid Arthritis.

Baricitinib is a Janus kinase (JAK) inhibitor. JAKs are tyrosine protein kinases that play an important role in pro-inflammatory signaling pathways. Overactive JAKs have been implicated in autoimmune disorders, such as rheumatoid arthritis. By inhibiting the actions of JAK1 and JAK2, baricitinib attenuates JAK-mediated inflammation and immune responses.

Baricitinib was first approved by the European Commission (EC) in February 2017 for the treatment of rheumatoid arthritis in adults and was later approved by the FDA in 2018. The EC later approved baricitinib for the treatment of atopic dermatitis. While baricitinib was granted emergency use as a treatment for COVID-19 in combination with remdesivir under the Emergency Use Authorization (EUA) in November 2020, the FDA fully approved the use of baricitinib for the treatment of COVID-19 in May 2022.

The CDSCO notification, referring to Eli Lilly’s request, stated:

"As per the request submitted by you, this office acknowledges withdrawal of the following approved indications for Baricitinib Tablets 2mg & 4mg for restricted use in emergency situations and respective permissions: --

1. Indication approved vide permission no. IMP/FF/SND/69/2021 dated 03-May2021:Baricitinib, in combination with Remdesivir, for the treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID 19) in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

2. Indication approved vide permission no. IMP/SND/21/000104 dated 15-Nov2021:Baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECМО)."