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Announcement / Media Room
Ipca to market NovaLead’s patented, repurposed drug Diulcus® for the treatment of Diabetic Foot Ulcer (DFU)
The approval is based on Phase III study which established that NovaLead’s patented drug branded as Diulcus®, which will be marketed in India by Ipca Laboratories Ltd. Diulcus® promotes the complete closure of DFU significantly better than Standard of Care, which is the present treatment of choice. Currently there is a global unmet medical need for the treatment of DFU.
With over 15% Diabetic patients suffering from DFU at least once in their lifetime, DFU is the most prevalent complication caused by chronic diabetes. The approval of this patented repurposed drug is significant because DFU is the leading cause for lower limb amputations globally.
The approval of Diulcus® marks a pivotal moment for the people suffering from DFU, who until now had few effective drug options for complete wound closure. With 20% higher incidence of complete wound closure among DFU patients demonstrated in its pivotal Phase III trial over current standard of care, Diulcus® provides significantly superior treatment option to physicians treating DFU patients. Approval of Diulcus is also a demonstration of effective Public-Private partnership as its development was part funded through Grant-In-Aid from BIRAC, a Government of India initiative.
Diulcus® is a novel topical formulation of an active pharmaceutical ingredient which was originally approved for the treatment of Tachycardia as an intravenous injection. NovaLead has been granted patents for it in several countries including regulated markets of USA, EU and Japan.
Diulcus® will be made available to the patients of DFU by Ipca Laboratories Ltd. (Ipca) through an exclusive IP licensing arrangement with NovaLead for Indian market.
“We are delighted to partner with NovaLead through an IP Licensing arrangement to bring Diulcus® for DFU patients in India. It demonstrates Ipca’s commitment towards to patients suffering from unmet medical need of DFU management and its focus on the diabetic sector. We are lining up for making Diulcus® available in India market from August, 2024.” Said Mr. Premchand Godha, Executive Chairman of Ipca Laboratories Ltd.”
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. Over 15% 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 Diulcus (Esmolol Hydrochloride)
- Diulcus® is a prescription medicine used to treat people with diabetic foot ulcer with no clinical infection. Infected DFUs need to be first treated for infection if existing and then put on Diulcus® treatment for wound closure. A doctor will perform independent assessment of DFUextent to determine the dose to be applied topically on the patient’s DFU. Treating clinicians are advised to refer to the full prescribing information of Diulcus®.
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