Stockholm, March 18, 2019. PledPharma AB (publ) today announces that the U.S. Food and Drug Administration (FDA) has granted an Orphan Drug Designation (ODD) to the drug candidate Aladote®, in development for reducing liver damage due to paracetamol overdose.
Today’s treatment for overdose of paracetamol, N-acetylcysteine (NAC), is most effective if given within eight hours of the overdose. Patients arriving later to the hospital, and for those with a severe overdose, there is a need for more efficacious treatment options. Aladote® is a first-in-class drug candidate in development to reduce liver damage due to paracetamol overdose.
The scientific rationale as well as clinical results from the completed proof-of-principle study indicate that Aladote® in combination with NAC has the potential to reduce liver damage in the specified patient population. PledPharma intends to conduct regulatory interactions to determine the next step in development of Aladote®.
“We are very positive and proud to receive Orphan Drug Designation for Aladote®. This confirms our development strategy to serve this unmet medical need. The ODD status can benefit patients by potentially resulting in shorter development time and for us also lead to lower development costs. In addition, we will receive further dedicated support from the FDA during the drug development process and seven years of market exclusivity.” says Nicklas Westerholm, CEO PledPharma AB.
Further information about ODD is presented at www.fda.gov.
