Hami's anti-obesity drug approved by FDA for rare pediatric disease program

SEOUL -- HM15136, an innovative anti-obesity drug under development by Hanmi Pharmaceutical, a major drugmaker in South Korea, has been approved by the U.S. Food and Drug Administration for a rare pediatric disease program.

HM15136, a biologic long-acting analog of glucagon, is being developed by Hanmi as a novel drug candidate to treat obesity with a once-weekly injection. The first-stage clinical trial is under way in the U.S to prove the efficacy of HM15136 for the treatment of congenital hyperinsulinism.

Congenital hyperinsulinism is a rare genetic disorder in which hypoglycemia is caused by excessive insulin secretion. Excess insulin causes low plasma sugar (hypoglycemia) or low blood sugar that can be very dangerous because the brain needs a constant source of sugar. The disease affects 1 in 25,000 to 50,000 babies.

Hanmi said in a statement that HM15136 was approved for a rare pediatric disease (RPD) program. "Through continuous research and development, we will contribute to improving the quality of life of patients around the world, including infants and children suffering from rare diseases," CEO Kwon Se-chang was quoted as saying.

A drug or biologic approved for an RPD program may qualify for a voucher that can be redeemed to receive a priority review of a subsequent marketing application for a different product.