Actemra FDA Approved for Systemic Sclerosis Interstitial Lung Disease Save

Genentech announced Thursday that the US Food and Drug Administration approved tocilizumab (Actemra) for the treatment of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD), specifically indicated for slowing the rate of decline in pulmonary function in adults SSc-ILD.

Tocilizumab is the first biologic, but second drug (following ninteninib), to be approved to curtail the worsening of SSc-ILD.

Systemic sclerosis is affects nearly 75,000 people in the United States and approximately 80% of SSc patients may develop SSc-IILD, a complication that carries significant morbidity and mortality risk.   Approval is based on the results of focuSSed trial wherein TCZ reduced the rate of lung function decline when compared to placebo treated patients. 

The focuSSced trial was a Phase III, 48 week study of 212 SSc patients who were randomized to TCZ or PBO; in this study nearly two-thirds of patients had SSc-ILD at baseline. There was no significant effect on SSc skin disease (the primary endpoint), as measured by the mRSS, in both the focuSSced and faSScinate trials.  Post-hoc analyses of the focuSSced trial demonstrated less decline over 48 weeks in forced vital capacity (FVC) compared to placebo (0.07% vs. -6.4%, mean difference 6.47%). 

The safety profile of TCZ in both focuSSced and faSScinate studies did not vary with that previously observed in other indications.

Tocilizumab is now FDA approved for use in rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic JIA, cytokine release syndrome and now, SSc-ILD.