Nintedanib as an anti-fibrotic medicine is already approved in more than 70 countries for the treatment of patients living with idiopathic pulmonary fibrosis.
Systemic sclerosis, also known as scleroderma, is a rare disease characterised by thickening and scarring of connective tissue throughout the body.
The disease can cause scarring of the skin, lungs (interstitial lung disease), heart and kidneys which can be debilitating and may become life-threatening.
Approximately 25% of patients develop significant pulmonary involvement within three years of diagnosis.
Lung involvement is the leading cause of death among people with systemic sclerosis.
The regulatory submissions are part of Boehringer Ingelheim's ongoing commitment to improving the lives of people living with pulmonary fibrosis, in particular those affected by rare diseases with a high level of unmet need.
Clinical research results relating to nintedanib in SSc-ILD will be shared with the scientific community during the American Thoracic Society Congress (17-22 May).
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial