Shots:

• The approval is based on P-III focuSSced trial assessing Actemra (SC- 162mg) vs PBO in a ratio (1:1) in 212 adults with SSc. The data from P-I/II fascinate study also supported the approval
• The P-III study did not meet its 1EPs i.e. change from baseline @48wks. in mRSS. In subgroup patients- decline in mean ppFVC (0.07% vs -6.4%-); change in mRSS (-5.88 vs -3.77)
• In general- the therapy reduced the rate of progressive loss of lung function in people with SSc-ILD. Actemra is the 1st FDA approved therapy and had received PRD for the treatment of SSc-ILD

 ­ Ref: Roche | Image: Roche