Amryt Pharma's drug compound gains FDA approval

The US Food and Drug Administration (FDA) has granted orphan drug designation to AIM-listed Amryt Pharma’s drug compound which has the potential to treat acromegaly.

The drug compound, AP102, now qualifies for tax credits for qualified clinical trials and market exclusivity on regulatory approval.

Acromegaly, a rare endocrine disorder where the body produces excessive growth hormones, which leads to abnormal growth throughout the body over time, affects four to 13 people in every 100,000.

Chief executive Joe Wiley said: "We believe that AP102 has the potential to improve outcomes for patients facing this debilitating disease and receiving the FDA's orphan drug designation marks an important regulatory milestone for Amryt as we prepare to bring AP102 into the clinic next year."

The FDA's orphan drug designation program provides orphan status to drugs and biologics that are being developed to address rare diseases or disorders that affect fewer than 200,000 people in the US.

Shares in Amryt Pharma were up 4.27% to 15.64p at 1013 GMT.