Jubilant Pharma Ltd., a subsidiary of Jubilant Pharmova Ltd., has announced the successful completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of Remdesivir. The drug is currently commercially available as an injectable formulation and is being used in the treatment of COVID-19.
Jubilant has sought authorisation for additional studies for this formulation from the Drug Controller General of India (DCGI). The proposed oral treatment is expected to lastbe for five days, a duration similar to the injectable dosage form.
“It is specifically designed to avoid hepatic metabolism which results in almost complete first-pass clearance/elimination of Remdesivir when it is administered by the traditional oral route. The findings from both preclinical and human studies indicate that the drug is able to undergo absorption when administered using the novel oral formulation,” the company said in a statement.
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“The novel formulation was well tolerated by all the study subjects with no additional safety/ tolerability profile as compared to the injectable product,” it said.
In May 2020, Jubilant entered into a non-exclusive licensing agreement with Gilead Sciences, Inc. that had granted it the right to register, manufacture and sell Gilead’s Remdesivir in 127 countries, including India.
On July 20, 2020, Jubilant received approval from the Drug Controller General of India (DCGI) to manufacture and market the antiviral drug remdesivir (JUBI-R) for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19.
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“Once approved, this will not only provide a more convenient and easy-to-administer formulation but also support an increasing demand of COVID-19 treatments.” said Shyam S. Bhartia, chairman and Hari S. Bhartia, co-chairman and MD, Jubilant Pharmova Ltd.