2011 | 2014 |
Pirfenidone approved by EMA | Pirfenidone approved by the US FDA: evidence on efficacy and safety observed in previous studies reinforced (ASCEND trial) [33] |
Triple therapy out | Nintedanib approved by the US FDA [33], CHMP of EMA positive opinion: second antifibrotic drug with positive effects in two phase III trials (INPULSIS trials) [34] |
Anticoagulants out | NAC monotherapy out (PANTHER trial) [21] |
EMA: European Medicines Agency; FDA: Food and Drug Administration; ASCEND: Assessment of Pirfenidone to Confirm Efficacy and Safety in IPF; CHMP: Committee for Medicinal Products for Human Use; NAC: N-acetylcysteine.