NovaLead's Patented Repurposed Drug receives approval from CDSCO for the treatment of Diabetic Foot Ulcer (DFU) for India market
New Delhi: NovaLead Pharma Private Limited (NovaLead), the pioneer of drug repurposing in India announced today that the drug regulator in India, CDSCO has approved their patented Repurposed Drug for treatment of Diabetic Foot Ulcer (DFU) which is a global unmet medical need.
With over 15% -25% of diabetic patients suffering from DFU at least once in their lifetime, DFU is the most prevalent complication caused by chronic diabetes. The approval of NovaLead’s patented repurposed drug is significant because DFU is the leading cause for lower limb amputations globally, with about 100,000 annual incidences in India alone.
“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.” said Supreet Deshpande, Chief Executive Officer at NovaLead Pharma Pvt. Ltd., Pune – India.
“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.” said Dr. Sudhir Kulkarni, Vice President- Discovery, at NovaLead.
This drug is a novel topical gel formulation of Esmolol hydrochloride, which is already approved in several countries for cardiac conditions via intravenous injection. Thus, this novel topical gel discovered and developed by NovaLead is a new indication as well as new formulation to be first launched in India. NovaLead has been granted patents for this drug in several countries including regulated markets of USA, EU and Japan.
Atul Aslekar, COO of NovaLead, mentioned that “a start-up traversing the highly challenging drug development cycle right from discovery to approval, spanning over a decade and half, makes NovaLead a unique success story in Indian pharma”.
“The drug will be made available to the patients of DFU in India by one of the leading Indian pharmaceutical companies through an exclusive IP licensing arrangement with NovaLead. Going forward, NovaLead will focus on the development of this repurposed drug for regulated markets of USA and Europe.” said Supreet Deshpande.
About Diabetic Foot Ulcer (DFU)
Over 537 million adults are living with diabetes globally and the number is predicted to rise to 643 million by 2030. About 15-25% of diabetics suffer from DFU, at least once in lifetime, with 25% of DFUs eventually requiring amputation. DFU is a leading cause of lower extremity amputation. The five-year mortality post amputation is 46%. DFU is a serious disease with very limited drug options and very high cost of treatment.
About the Drug (Topical gel of Esmolol Hydrochloride)
It will be a prescription medicine used to treat people with diabetic foot ulcer without active clinical infection. Infected DFUs need to be first treated for infection if existing and then put on the drug treatment for wound closure. A doctor will perform independent assessment of DFU to determine the dose to be applied topically on the patient’s DFU.
About NovaLead Pharma Private Limited (NovaLead)
NovaLead is a pioneer of drug repurposing in India and one of the few companies globally to have completed the whole cycle from discovery to regulatory approval successfully for a repurposed drug. Headquartered in Pune, India NovaLead’s research focus is to find novel repurposed drug treatment for unmet medical needs.
