Hetero Drugs has received the Drugs Controller General of India (DCGI) emergency use approval for a generic version of Roche’s drug, tocilizumab, to treat Covid-19 in adults.
The Indian pharmaceutical firm intends to manufacture the drug at its facility in Hyderabad and commercialise it in India by the end of this month, under the brand name Tocira.
Tocilizumab is an anti-IL-6 receptor (aIL-6R) therapy and is believed to play an important role in activating RA and other inflammatory autoimmune conditions.
It has been approved in 116 countries to treat rheumatoid arthritis (RA), paediatric juvenile idiopathic arthritis (pJIA), giant cell arteritis (GCA) and CAR-T cell-induced cytokine release syndrome (CRS).
In June this year, Roche has secured the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for tocilizumab to treat severe Covid-19.
The US regulator indicated the drug for hospitalised Covid-19 patients, who are on systemic corticosteroids and in need of supplemental oxygen.
The results from the RECOVERY trial showed positive results for tocilizumab in treating Covid-19.
In the study, the drug reduced the risk of death, time to recovery and need for mechanical ventilation in patients hospitalised with severe Covid-19.
In July, Hetero submitted an application to the Indian regulator seeking emergency use approval for Merck’s Covid-19 drug molnupiravir.
Molnupiravir is an antiviral drug developed by Merck and Ridgeback Biotherapeutics for the treatment of non-hospitalised Covid-19 patients.
The submission was based on interim data from a late-stage trial, which showed that molnupiravir reduced hospitalisations and speed up recovery in mild cases.
