NovaLead Pharma has received approval from the Central Drugs Standard Control Organisation (CDSCO) for its innovative repurposed drug, designed to treat Diabetic Foot Ulcer (DFU). This significant development addresses a critical global health challenge, the company announced on Tuesday.
Background:
Diabetic Foot Ulcer is a common complication of chronic diabetes, affecting 15% to 25% of diabetic individuals at some point in their lives. It is a major cause of lower limb amputations, with approximately 100,000 cases reported annually in India alone. NovaLead’s newly approved drug offers a promising solution for patients with limited treatment options for achieving complete wound closure.
Details of the Drug:
The drug, a novel topical gel formulation of Esmolol hydrochloride, is traditionally used intravenously for cardiac conditions. NovaLead’s formulation repurposes this drug for DFU, marking a significant advancement in treatment. The gel will initially be available in India and has been patented in several countries, including the USA, EU, and Japan.
Statements from NovaLead Executives:
Supreet Deshpande, CEO of NovaLead Pharma, emphasized the importance of the approval, noting that it represents a major breakthrough for DFU patients. “This drug’s approval is a testament to the effectiveness of public-private partnerships, with its development partially funded by BIRAC, an initiative of the Government of India,” Deshpande said.
Sudhir Kulkarni, Vice President of Discovery at NovaLead, explained the rigorous development process. “Despite being a repurposed drug, it underwent comprehensive preclinical and clinical investigations, prioritizing patient safety. The approval is based on statistically significant positive outcomes compared to standard care in a randomized, double-blind Phase 3 clinical trial,” Kulkarni added.
Future Plans:
The drug will be distributed to DFU patients in India through an exclusive intellectual property licensing agreement with a leading Indian pharmaceutical company. Looking forward, NovaLead aims to expand the drug’s availability to regulated markets in the USA and Europe.
Atul Aslekar, COO of NovaLead, reflected on the company’s achievements, stating, “Navigating the complex drug development process from discovery to approval over the past decade and a half highlights NovaLead’s unique success story in the Indian pharmaceutical industry.”
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