Shots: The FDA’s approval is based on P-III INBUILD study assessing Ofev (150mg, bid) vs PBO in 663 patients with chronic fibrosing ILDs with a progressive phenotype for 52wks. at […]readmore
Tags : nintedanib
Shots: The EMA’s CHMP has granted a positive opinion, recommending MAA for nintedanib to treat SSc-ILD in adults. The positive opinion is based on P-III SENSCIS study assessing nintedanib (150mg, […]readmore
Shots: Health Canada approved Ofev (nintedanib) as the first and only treatment, indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease […]readmore
Shots: The BT designation is based on P-III INBUILD study results assessing OFEV vs PBO in patients with chronic fibrosing interstitial lung disease (ILDs) with signs of progression for 52 […]readmore
Shots: The P-III INBUILD trial involves assessing of OFEV vs PBO in patients with chronic fibrosing interstitial lung disease (ILDs) with signs of progression for 52 wks. P-III INBUILD study […]readmore
Regulatory
Boehringer Ingelheim’s Ofev (nintedanib) Receives FDA’s Advisory Committee Recommendation for
Shots: The FDA’s Arthritis Advisory Committee recommended (10-7 vote) to approve Ofev for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) The FDA’s recommendation is based on P-III SENSCIS […]readmore
Shots: The INMARK study involves assessing of Ofev (nintedanib) vs PBO in 347 patients with IPF for 12 wks., followed by an open label period of 40 wks. The study […]readmore