- 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, bid) vs PBO in 576 patients with SSc-ILD across 32+ countries
- The P-III SENSCIS results demonstrated a 44% loss of pulmonary function as measured in FVC, skin thickness as measured by the change in mRSS and QoL measured by SGRQ @52wks.
- Nintedanib is an approved therapy in 70+ countries for the treatment of patients with IPF and has received FDA’s approval as the first therapy to slow the rate of decline in pulmonary function in patients with SSc-ILD in Sept’2019
Click here to read full press release/ article | Ref: Boehringer Ingelheim | Image: StraitTimes