Jubilant Pharmova subsidiary Jubilant Pharma has concluded safety and pharmacokinetic/absorption studies of a new oral formulation of remdesivir in animals and healthy human volunteers in India.
Remdesivir is the first and only antiviral drug that has obtained the US Food and Drug Administration’s full approval for treating hospitalised Covid-19 patients.
The novel formulation can potentially lower the capacity constraint faced by the injectable form of remdesivir and guarantee broader and timely availability for the patients.
The oral formulation is designed to side-step hepatic metabolism, which causes complete first-pass elimination of the drug when administered orally through traditional means.
According to the latest findings from both preclinical and human studies, remdesivir was shown to undergo absorption on administering as an oral formulation.
Furthermore, oral remdesivir was observed to be well tolerated in all the study subjects with no new safety/ tolerability issues when compared to the injectable dose.
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Jubilant has sought permission from the Drugs Controller General of India (DCGI) to carry out further studies of the oral formulation.
The proposed oral form also has a treatment duration of five days similar to the injectable dosage form.
The company intends to offer a reasonably priced, more convenient and potentially effective treatment option for Covid-19 patients.
Jubilant Pharma CEO Pramod Yadav said: “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 increasing demand [for] Covid-19 treatments.”
In May last year, Jubilant signed a non-exclusive licencing agreement with Gilead Sciences, through which it secured the right to register, produce and sell the latter’s remdesivir in 127 countries including India.
In July, the DCGI granted permission for Jubilant to produce and market remdesivir (JUBI-R) for 100mg/vial (lyophilised injection) for restricted emergency use in India.