The FDA has granted Orphan Drug Designation to its product, PCS499, for treatment of necrobiosis lipoidica.
Today, Processa Pharmaceuticals, Inc announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to its product, PCS499, for treatment of necrobiosis lipoidica.
In the United States, approximately 74,000 - 185,000 people in the United States and 200,000 — 500,000 people worldwide are impacted by necrobiosis lipoidica. Non-diabetic patients are included in these statistics as well as 0.3% of all diabetic patients.
The disease is characterized as a multi-faceted disorder affecting the skin along with the tissue under the skin. It occurs in women/men 20 — 60 years of age and has the potential to last for months or years.
"We are very pleased that PCS499 has received Orphan Drug Designation from FDA for the treatment of necrobiosis lipoidica,” said Dr David Young, CEO Processa Pharmaceuticals, Inc in a recent statement. “Necrobiosis lipoidica can have a major impact on the quality of life of patients and PCS499 will be the first treatment targeted to this condition.”
Currently, no FDA approved treatment and no known biotech or pharma companies are developing a drug for necrobiosis lipoidica.
“We plan to begin our clinical studies in 2018 and to accelerate the development of PCS499 in order to provide clinical benefit to necrobiosis lipoidica patients as soon as possible.”