Jubilant Pharma Limited, a subsidiary of Jubilant Pharmova Limited, has completed safety trials in animals and healthy human volunteers in India using a novel oral formulation of remdesivir, which is likely to be more effective and viable than the commercially available injectable formulation. Jubilant has now sought approval for additional studies for this novel oral formulation from the Drug Controller General of India (DCGI).
The company said the oral formulation is an affordable, more convenient, easy-to-administer and potentially effective treatment option for COVID-19 patients. The proposed oral treatment is expected to be for five days. Remdesivir is the first and the only antiviral drug fully approved by the US FDA (Food and Drug Administration) for the treatment of patients with COVID-19 requiring hospitalisation.
The new formulation is likely to ease the capacity constraint that injectable formulation faces and ensure wider and timely availability for the patients of COVID-19. The findings from both preclinical and human studies show the drug can undergo absorption when administered using oral formulation. The oral formulation was well-tolerated by all respondents as compared to the injectable product.
In May 2020, Jubilant entered into an agreement with Gilead Sciences Inc that granted it the right to register, manufacture and sell Gilead's remdesivir in 127 countries, including India. On July 20, 2020, Jubilant received approval to make and market remdesivir for 100 mg/vial 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 increasing demand of COVID-19 treatments," said Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and MD, Jubilant Pharmova.
In view of the rising COVID-19 cases in the country and shortage of Remdesivir, the Centre has approved plan to step up production of the anti-viral drug used in the treatment of infection and to reduce its price. Amid shortage of the ket drug, it is likely that the Centre will grant the company approval within a short span of time.