Nerandomilast primary endpoint phase-3 FIBRONEER-IPF met
WEB6 days ago · Boehringer’s nerandomilast meets primary endpoint in pivotal phase-III FIBRONEER™-IPF study. Topline data from FIBRONEER™-IPF show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] at week 52 versus placebo. The FIBRONEER™-IPF trial is the ...
FIBRONEER-IPF Trial of Nerandomilast Meets Primary End Point
WEB3 days ago · They were divided into 3 groups, taking a dose of nerandomilast 9 mg, nerandomilast 18 mg, or placebo twice daily. The primary end point was absolute change in FVC—a key measure of lung function ...
Nerandomilast Shows Promise in Idiopathic Pulmonary Fibrosis Trial
WEB5 days ago · IPF is a rare progressive fibrosing interstitial lung disease with symptoms that include breathing difficulty, dry and persistent cough, chest discomfort and fatigue. The randomized, double-blind, placebo-controlled FIBRONEER-IPF trial (ClinicalTrials.gov Identifier: NCT05321069) enrolled 1177 patients aged 40 years and older with IPF.
Boehringer seeks approval for lung fibrosis drug following Phase …
WEB6 days ago · The Phase III FIBRONEER-IPF trial enrolled 1,177 patients with IPF randomised to receive either nerandomilast or placebo twice daily. The study’s secondary endpoint is time to the first occurrence of acute IPF exacerbation, first hospitalisation for respiratory cause, or death.
Positive topline data reported in phase 3 trial of nerandomilast in ...
WEB5 days ago · Adults with idiopathic pulmonary fibrosis met the primary endpoint of absolute change in FVC with 52-week oral nerandomilast, an investigational phosphodiesterase 4B inhibitor, vs. placebo ...
Boehringer’s nerandomilast Phase III win sets stage for FDA filing
WEB6 days ago · Based on these results, Boehringer said it will submit the new drug application (NDA) for nerandomilast for the treatment of IPF to the US Food and Drug Administration (FDA) and other health authorities worldwide. The FDA granted Breakthrough Therapy designation for the drug in IPF in 2022. ... All the news that …
Boehringer’s nerandomilast meets primary endpoint in pivotal …
WEB6 days ago · The FDA granted Breakthrough Therapy Designation in IPF in 2022. 2. “This is the first IPF phase-III-trial in a decade to meet its primary endpoint 9,” said Ioannis Sapountzis, Head of Global ...
Trial sets up filings for Boehringer IPF drug nerandomilast
WEB5 days ago · Nerandomilast (BI 1015550) has been highlighted for some time as Boehringer's best chance to defend its IPF business in the coming years. Ofev contributed €3.5 billion of the company's total ...
Boehringer Aces Phase III Pulmonary Fibrosis Trial, Plans FDA ...
WEB5 days ago · Monday’s Phase III win positions nerandomilast as a potential successor to Boehringer’s Ofev (nintedanib), which is also indicated for IPF to slow disease progression. In 2023, Ofev was one of the pharma’s top-performing assets, growing 12.8% year-over-year and bringing in more than $3.9 billion. Phase III Regulatory FDA.
Boehringer’s nerandomilast meets primary ... - Boehringer …
WEBTopline data from FIBRONEER TM-IPF show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in Forced Vital Capacity [mL] at week 52 versus placebo.; The FIBRONEER TM-IPF trial is the largest trial in idiopathic pulmonary fibrosis (IPF) conducted to date.Patients were recruited in over 330 sites and in over 30 countries. 1,5
- Some results have been removed