Boehringer Ingelheim USA Corporation

Boehringer Ingelheim's nerandomilast met primary endpoint in Phase III FIBRONEER-IPF study, significantly improving lung function in IPF patients. The drug targets PDE4B enzyme to exert anti-fibrotic and anti-inflammatory effects. Boehringer plans to use study results for FDA and global regulatory submissions, with full data expected in H1 2025.

Phase 3 FIBRONEER-IPF trial met primary endpoint with nerandomilast in adults with IPF, showing absolute change in FVC. Boehringer Ingelheim plans to submit a new drug application to the FDA and present full findings in early 2025.

Boehringer Ingelheim seeks approval for nerandomilast after Phase III trial in idiopathic pulmonary fibrosis met primary endpoint. The trial, FIBRONEER-IPF, improved forced vital capacity after 52 weeks. Nerandomilast, a PDE4B inhibitor, received breakthrough therapy designation in 2022 and is also being tested in progressive fibrosing interstitial lung diseases.

Boehringer Ingelheim's nerandomilast met primary endpoint in phase 3 trial for idiopathic pulmonary fibrosis (IPF), marking the first successful IPF phase-3 trial in a decade. The oral drug, a preferential inhibitor of phosphodiesterase 4B, received FDA breakthrough therapy designation in 2022. Boehringer plans to submit a new drug application to the FDA and other regulators based on these positive results.

The HIMALAYA study's 5-year survival analysis shows 19.6% survival with STRIDE (durvalumab plus tremelimumab) vs 9.4% with sorafenib in unresectable hepatocellular carcinoma, with no new safety concerns.

FIBRONEER™-IPF trial met primary endpoint: absolute change in Forced Vital Capacity at week 52. Boehringer Ingelheim to submit nerandomilast for IPF treatment to FDA and other Health Authorities worldwide.

GLP-1 meds like Ozempic reduce risk of cirrhosis and death in diabetes patients with metabolic dysfunction-associated steatotic liver disease (MASLD), according to a study in JAMA Internal Medicine. Semaglutide (Ozempic/Wegovy) was particularly effective if taken early in MASLD progression. GLP-1s work by reducing body weight, blood sugar, and inflammation, potentially reversing fatty liver disease.

A multinational clinical trial, EASi-KIDNEY, will evaluate whether vicadrostat (BI 690517) combined with empagliflozin reduces CKD progression, heart failure hospitalization, or cardiovascular death. The trial, involving 11,000 participants across 15-20 countries, aims to provide robust evidence for new treatments. Initial results are expected by 2028/2029.