Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

 Roche’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

Genentech’s Actemra/RoActemra (tocilizumab) Receives the US FDA’s Approval as the First Biologic for Systemic Sclerosis-Associated Interstitial Lung Disease

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

Click here ­to­ read full press release/ article | Ref: Roche | Image: CTV News

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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