The U.S. Food and Drug Administration (FDA) has granted orphan drug status to SM04646, a therapy developed by San Diego-based Samumed to treat idiopathic pulmonary fibrosis (IPF). This designation provides several benefits, including tax incentives, exemption from the FDA user fee and potential market exclusivity for seven years following approval. SM04646,…
News
Ofev (nintedanib) can counter lung fibrosis by correcting abnormalities in lung blood-vessel structure, according to a German study in mice. The research suggests that fibrosis, or tissue scarring, and mechanisms involved in blood vessel formation interact in the progression of the disease. Researchers at the Johannes Gutenberg University Medical Center in Mainz studied…
ZappRx’s new digital platform for prescribing specialty medications, including therapies to treat pulmonary fibrosis, can now be used at two centers with expertise in respiratory conditions —  Arizona Pulmonary Specialists and Harbor-UCLA Medical Center. The platform was designed to speed up and simplify the complex process required to order…
Patients with idiopathic pulmonary fibrosis (IPF) prescribed Ofev (nintedanib) or Esbriet (pirfenidone) in real-world practice have shown similar tolerability and adverse event profiles as those reported in large-scale clinical trials testing these drugs, according to recent research. For many decades, IPF treatment was limited to supportive care…
Samumed’s nebulized inhalation solution SM04646, a candidate therapy to treat idiopathic pulmonary fibrosis (IPF), was found to be well-tolerated and to cause no serious adverse effects in a Phase 1 trial of healthy individuals in Australia. These results support the launch of future clinical trials to test the drug’s efficacy in IPF patients. According to…
Esbriet (pirfenidone) and Ofev (nintedanib) remain the most reliably effective treatments for idiopathic pulmonary fibrosis (IPF), according to a study that used a time-course model to compare the effectiveness of various approved and experimental drugs. But a compound now in development might challenge their position. The analysis found that…
A specific subpopulation of immune cells — known as monocyte-derived alveolar macrophages — was found to play an essential role in the development of pulmonary fibrosis (PF). This finding not only contributes new knowledge about the underlying mechanism of PF, but also paves the…
Researchers from two Southern U.S. universities and a federal healthcare agency have begun a study of pulmonary fibrosis in people with the rare disease Hermansky-Pudlak syndrome (HPS). The objective of the observational clinical trial is to learn why those with HPS develop lung fibrosis, or tissue scarring. The team from …
A University of Southern California researcher has received a $6.9 million U.S. government grant to continue her work on lung cell regeneration as a way of treating such diseases as pulmonary fibrosis and chronic obstructive pulmonary disease. Dr. Zea Borok of the university’s Keck School of Medicine received the seven-year grant under the National Heart, Lung, and…
Managing lung cancer in idiopathic pulmonary fibrosis patients is difficult, largely because standard lung cancer treatments create a risk of IPF exacerbations and patients dying early. An Italian study that covered four patients suggests that Boehringer Ingelheim’s Ofev (nintedanib) could be an answer. The research, “Lung Cancer in Patients with…
