FDA Grants Orphan Drug Designation to HM15211 for Idiopathic pulmonary fibrosis (IPF)

Hanmi Pharmaceutical’s LAPS Triple Agonist (HM15211) has been designated an orphan drug to treat Idiopathic pulmonary fibrosis (IPF). Pulmonary fibrosis affects the interstitium, the lung tissue that serves as a scaffold for the alveoli. Fibrosis thickens the interstitium and stiffens the alveoli, preventing them from fully expanding and holding as much air as they should. This thickening also restricts the passage of oxygen into the bloodstream through the alveoli wall.

Publish Date: 12-05-2021   Source- Hanmi Pharmaceutical

Idiopathic pulmonary fibrosis (IPF) is a rare, chronic, and progressive fibrosing interstitial pneumonia that affects middle-aged and older people. It causes thickening, stiffening, or persistent and progressive scarring (fibrosis) in lung tissue (particularly alveoli), which worsens irreversibly over time. Scarring reduces the amount of oxygen in the blood by affecting the air sacs. Breathlessness can result from everyday activities such as walking when there is a lack of oxygen in the blood. In Idiopathic Pulmonary Fibrosis (IPF), characterized by progressive worsening of dyspnea and lung function and is associated with a poor prognosis, the rate of progression varies depending on the individual. ‘Diffuse Parenchymal Lung Diseases,’ a broader umbrella of ‘Interstitial Lung Diseases,’ is another name for this group of lung disorders (IDLs).

• IPF is a group of lung diseases that cause damage to the lungs due to unknown causes; however, genetic susceptibility accounts for 35 to 40% of cases. The lack of a cure affects approximately 132,000 people in the United States, with about 50,000 new diagnoses yearly.

However, the current Idiopathic pulmonary fibrosis (IPF) treatment market share, market uptake, and attribute analysis concerning the 16 most potential emerging therapies (Pemrevlumab, KD025, PRM151, Tipelukast, CC 90001, PBI-4050, TD139, GLPG 1690, GLPG 1205, VAY 736, TAS115, ART-123, LT-1001, LT-1002, INOpulse, BMS 986263) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for Idiopathic pulmonary fibrosis (IPF) treatment. The key companies in to advance stage of results are Roche, MediciNova, Galecto Biotech, Liminal BioSciences, Sanofi, Biogen, Fibrogen, Galapagos, Kadmon Corporation, Afferent Pharmaceuticals, GlaxoSmithKline, Boehringer Ingelheim, Vicore Pharma, Bristol-Myers Squibb, Pliant Therapeutics, Novartis, Asahi Kasei Pharma, etc. targeting IPF.

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Idiopathic pulmonary fibrosis (IPF) to provide a clear understanding of the disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.