BDR Pharma has signed a license agreement with the Defence Research and Development Establishment (DRDE) and the Institute of Nuclear Medicine and Allied Sciences (INMAS) of the Defence Research and Development Organisation (DRDO) for the manufacturing, distribution and marketing of 2- Deoxy-D-Glucose (2-DG) in India, a company statement said.
Last month, the Drugs Controller General of India (DCGI) had approved the oral medication for emergency usage as adjuvant therapy in mild-to-severe COVID-19 patients, it mentioned.
The statement also said that the DRDE in Gwalior had produced 2-DG. The clinical trials were carried out in collaboration with Dr Reddy’s Laboratories by INMAS, a DRDO lab. After receiving positive responses in phase-II and phase-IIb trials, DCGI permitted 2DG phase-III trials in November 2020. The phase-II trial, which lasted from December 2020 to March 2021, enrolled 220 patients. The medicine was discovered to speed up the recovery of COVID-19 patients in hospitals and to lessen the need for supplementary oxygen in them.
Commenting on the development, Dharmesh Shah, CMD, BDR Pharmaceuticals, expressed, “We are pleased to secure a licence from the DRDO and added 2-Deoxy-D-Glucose to our COVID product offering. This arrangement aims to ensure that this drug reaches as many eligible Indian patients as possible who are suffering from the devastating pandemic. Our aim is to ramp up the availability of successful treatment and coordinate manufacturing so that there is no scarcity of drugs to give to people fighting the disease. We expect that by widening and deepening the identification and development of COVID-19 therapy options, this collaboration can address more unmet medical needs.”
The statement added that the clinical trial data supplied by the government based on the emergency approval demonstrated that the chemical aids in the speedier recovery of COVID-19 patients and minimises their reliance on supplementary oxygen. In addition, the medication builds up in virus-infected cells and stops viral manufacturing and energy production, preventing the virus from spreading.
The product will be priced competitively and will be available in powder form in a sachet that can be consumed orally after being dissolved in water. BDR has applied to the DCGI for restricted emergency use authorisation to manufacture Drug 2-DG to treat COVID-19 patients in India. For the development of 2-DG drugs, the DRDO has recently signed agreements with four major Indian generic medicine producers, notified the statement.