Jubilant seeks DGCI authorization for oral Remdesivir next steps

Jubilant received DGCI approval for injectable Remdesivir in July 2020

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Jubilant is seeking approval from DGCI to take its oral Remdesivir forward Photo Julia Zyablova via Unsplash
Jubilant is seeking approval from DGCI to take its oral Remdesivir forward Photo Julia Zyablova via Unsplash

On 19 April 2021, Noida-Delhi NCR-based Jubilant Pharmova announced the development of a novel oral formulation of Remdesivir by its subsidiary Jubilant Pharma with the successful completion of safety and pharmacokinetic / absorption studies in animals and healthy human volunteers. Jubilant has sought authorization for additional studies for its oral formulation from the Drug Controller General of India (DCGI).

The company hopes to provide an affordable, more convenient, easier-to-administer, and potentially effective treatment option for Covid-19 patients. The proposed oral treatment over five days is similar to the injectable dosage. Remdesivir is the first and the only anti-viral drug fully approved by the US FDA to treat patients with Covid-19 requiring hospitalization.

This Jubilant formulation is likely to ease the capacity constraints that the injectable formulation faces for broader and more timely availability for Covid-19 patients. It is specifically designed to avoid hepatic metabolism, which results in almost complete first-pass clearance/elimination of Remdesivir when administered by the traditional oral route. The findings from both preclinical and human studies indicate that the drug can undergo absorption when administered using the novel oral formulation. The novel formulation was well tolerated by all the study subjects with no additional safety/tolerability profile than the injectable product.

In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences that granted it the right to register, manufacture and sell Gilead’s Remdesivir in 127 countries, including India. On 20 July 2020, Jubilant received approval from the Drug Controller General of India (DCGI) to manufacture and market the anti-viral drug Remdesivir (‘JUBI-R’) for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe Covid-19.

“We are pleased to announce the ongoing development of a novel formulation of Remdesivir to address the pandemic at this critical juncture. Once approved, this will not only provide a more convenient and easy-to-administer formulation but also support the increasing demand of Covid-19 treatments,” stated Shyam S Bhartia, chairman, and Hari S Bhartia, co-chairman and managing director, Jubilant Pharmova Limited.

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