Central Drugs Standard Control Organisation (CDSCO) has approved NovaLead Pharma's patented repurposed drug for the treatment of Diabetic Foot Ulcer (DFU). This approval addresses a significant global unmet medical need, the company said in a press statement on Tuesday.
DFU is a prevalent complication of chronic diabetes, affecting 15 per cent-25 per cent of diabetic patients at least once in their lifetime. It is also the leading cause of lower limb amputations worldwide, with approximately 100,000 cases annually in India. The approval of NovaLead’s drug is a breakthrough for patients who previously had limited treatment options for complete wound closure, the press statement read.
Supreet Deshpande, CEO of NovaLead Pharma, stated, “The approval of this drug marks an important moment for people suffering from DFU, who until now had limited drug options for complete wound closure. Approval of this drug is also a demonstration of effective Public-Private partnership as its development was part funded by BIRAC, a Govt. of India initiative.”
Sudhir Kulkarni, Vice President of Discovery at NovaLead, added, “Although it is a repurposed drug, we developed it as a new drug with comprehensive preclinical and clinical investigations, keeping patient safety at the forefront. Its approval is based on statistically significant positive results over standard of care treatment in a randomised, double-blind Phase 3 clinical trial.”
The newly approved drug is a novel topical gel formulation of Esmolol hydrochloride, traditionally used for cardiac conditions via intravenous injection. This innovative gel formulation and a new indication for DFU will be first launched in India. NovaLead holds patents for this drug in several countries, including the USA, EU, and Japan.
Atul Aslekar, COO of NovaLead, highlighted the company's journey, saying, “A start-up traversing the highly challenging drug development cycle right from discovery to approval, spanning over a decade and a half, makes NovaLead a unique success story in Indian pharma.”
The drug will be made available to DFU patients in India through an exclusive IP licensing arrangement with a leading Indian pharmaceutical company. Looking ahead, NovaLead will focus on developing this repurposed drug for regulated markets in the USA and Europe, said Deshpande.
