Idiopathic Pulmonary Fibrosis
The primary objective was to characterize the long-term safety and tolerability of Ofev in patients with IPF; efficacy endpoints included annual rate of decline in forced vital capacity (FVC) calculated over 192 weeks.
The FDA's designation was based on data from a Phase 2 placebo-controlled trial that demonstrated pamrevlumab could potentially address an unmet medical need for this condition.
Targeting TGF-β signaling in a tissue-specific manner allows the drug to modulate the fibrotic cascade with maximum clinical effects while avoiding adverse events
The use of recombinant human pentraxin 2 vs placebo resulted in a slower decline in lung function over 28 weeks for patients with idiopathic pulmonary fibrosis.
RP5063 is a new chemical entity with a novel mechanism of multimodal modulation of serotonin and dopamine signaling pathways.
The patients began treatment with oral sirolimus; after 1 year of treatment, there was improvement in exertional dyspnea in all 3 patients.
Some substances used while conducting these tasks contained silica, polyvinyl siloxane, alginate, and other compounds with known or potential respiratory toxicity.