Originally published by Destiny Pharma, 28 August 2024. This regulatory milestone was achieved prior to AMR Bio’s acquisition of the XF platform. Since acquiring the XF assets, AMR Bio has completed the transfer of ownership and sponsorship of both the Investigational New Drug (IND) application for XF-73 Nasal and the pre-Investigational New Drug (pIND) application for XF-73 Dermal, along with the associated Qualified Infectious Disease Product (QIDP) designation and Fast Track status.
The US Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) designation to XF-73 Dermal Gel for the treatment or prevention of Staphylococcal (including MRSA) infections in burn wounds.
Globally, it is estimated that there are approximately 9 million burn cases per year. Burn injuries contribute to over 250,000 fatalities with infections identified as the cause of 61% of post-burn deaths. Recent reports show the incidence of sepsis in burn patients ranges from 8% to 42% with related mortality from 28-65%. Staphylococcus aureus (including MRSA) is a common cause of post-burn infection, with patients with burns reported to have a prevalence of S. aureus of 57.8%.
Under the US GAIN (Generating Antibiotic Incentives Now) Act, QIDP status confers FDA priority review, eligibility for fast-track status, and an additional five-year extension of US patent exclusivity when approval is granted.
XF-73 Dermal Gel development has been supported and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The Company has previously been successful in gaining QIDP status for XF-73 Nasal for the prevention of post-surgical staphylococcal (including MRSA) infections, further reinforcing the significant regulatory endorsement and recognition of XF-73’s potential in addressing the challenges of antimicrobial resistance.
Read the original announcement in full here: https://destinypharma.com/2024/08/28/fda-grants-xf-73-dermal-qipd-for-burn-wound-infections/