The FDA Orphan Drug Designation program grants a special status to drugs and biologics intended to treat, diagnose or prevent so-called orphan diseases and disorders that affect less than 200,000 people in the US.
The designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits, as well as a waiver of prescription drug user fee act (PDUFA) filing fees.
Amarantus president and chief executive officer Gerald Commissiong said: "This represents an important milestone for the company as well as a significant step forward for our clinical and regulatory strategy.
"Our goal is to continue to identify ways to build value into our MANF program and advance this promising product candidate in multiple therapeutic areas with significant unmet need."
Typically diagnosed in adolescents and young adults, RP is a group of inherited diseases causing retinal degeneration often leading to blindness by the age of 40.
MANF is believed to have broad potential in treatment of RP, as it is produced by the body for the purpose of reducing and preventing cell death in response to injury or disease, through the unfolded protein response.