Seeks drug regulator’s nod for additional studies

Jubilant Pharma Limited (JPL), a subsidiary of Jubilant Pharmova Limited, on Monday announced completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of Remdesivir against the commercially available injectable formulation of the medicine. Jubilant has sought authorisation for additional studies for this from the Drug Controller General of India (DCGI). “Jubilant is hoping to provide an affordable, more convenient, easy-to-administer and potentially effective treatment option for Covid-19 patients,” it said in a stock filing. “Once approved, this will provide convenient administration and support an increasing demand of Covid-19 treatments,” Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and Managing Director, JPL said.

USFDA nod

The proposed oral treatment is expected to be for five days, a duration similar to the injectable dosage form. Remdesivir is the first and the only anti-viral drug fully approved by the USFDA for the treatment of patients with Covid-19 requiring hospitalisation, it said. “This innovative formulation is likely to ease the capacity constraint that injectable formulation faces and ensure wider and timely availability for the patients. 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 company said.

The findings from both pre-clinical and human studies indicate that the drug is able to 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 as compared to the injectable product. In May last year, 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 July 20, Jubilant received approval from the DCGI to manufacture and market the antiviral drug Remdesivir (“JUBI-R”) for 100 mg/vial (lyophilised injection) for restricted emergency use in India for Covid-19 treatment. Source: thehindubusinessline