Medicus Pharma's D-MNA Gets FDA Minor Use In Major Species Designation (MUMS) Designation For Horse Cancer
Medicus Pharma's Doxorubicin microneedle patch for horse SCC received FDA's MUMS designation for market exclusivity.
Breaking News
Dec 13, 2024
Simantini Singh Deo

Medicus Pharma Ltd. announced that the U.S. FDA has granted Minor Use in Major Species (MUMS) designation to its Investigational New Animal Drug (INAD File No. 013880). The designation applies to the company’s dissolvable Doxorubicin-containing microneedle array (D-MNA) for treating external squamous cell carcinoma (SCC) in horses. The company received the notification on December 9, by2024.
Dr. Raza Bokhari, Executive Chairman & CEO, said in a statement, “In a relatively short period of time, we have made remarkable progress with the FDA in advancing the clinical development program of the veterinary application of our novel D-MNA patch in treating SCC in horses. Developing a non-invasive treatment for equine SCC represents an untapped market opportunity that we are excited to pursue. The MUMS designation is an important catalyst to provide us with a first mover advantage and also position us to possibly have a commercially viable product as early as 2026.”
MUMS status, akin to Orphan Drug designation for human medicines, grants a 7-year exclusive marketing period post-approval, provided all regulatory requirements are met. The D-MNA is a patented transdermal patch featuring cellulose-based microneedles loaded with doxorubicin at the tips. Once applied, the microneedles penetrate the skin’s outer layer, create microchannels, reach the tumour, dissolve, and deliver doxorubicin directly to eradicate cancer cells.