Daewoong Pharmaceutical said that the U.S. Food and Drug Administration had granted fast-track designation to its idiopathic pulmonary fibrosis (IPF) therapy, DWN12088.

IPF is a lung disease in which the lungs gradually harden and lose their function due to excessive fibrous tissue. It is a rare and intractable disease with a five-year survival rate of less than 40 percent after diagnosis. Multinational pharmaceutical companies market IPF treatments, but the drugs cannot completely stop the disease, and there is still a high unmet medical demand due to side effects.

DWN12088 suppresses excessive generation of collagen, the cause of fibrosis, by reducing Prolyl tRNA Synthetase (PRS) protein's effect on collagen production, according to Daewoong. The drug also won an orphan drug designation (ODD) status from the FDA to treat IPF in August 2019.

"IPF is a disease with a high unmet medical need despite the existing treatments," Daewoong Pharmaceutical CEO Jeon Seng-ho said. "The company will do its best to commercialize innovative new drugs as soon as possible by closely consulting with the FDA and speeding up development."

The FDA gives fast-track status to speed up the development of important new drugs that could treat severe illnesses and satisfy unmet patients' needs. The fast-track designation allows a company to apply for a license based on completed sections rather than waiting until the FDA's review ends. In addition, it cuts the agency’s priority review period from 10 months to six months.

Daewoong said it plans to become a game changer in the IPF treatment field by rapidly advancing into the global IPF treatment market with the FDA fast-track designation as an opportunity.

According to Research And Markets, a drug market research institute, the IPF treatment market is expected to reach $6.1 billion by 2030.