Roche: FDA Approves Actemra/RoActemra For Systemic Sclerosis-associated Interstitial Lung Disease


2021-03-15 21:30:26 RTTNews


Roche said FDA has approved Actemra/RoActemra subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. Actemra/RoActemra is the first biologic therapy approved for the treatment of the disease. The FDA approval is based on data from the focuSSced trial, a phase III randomised, double-blind, placebo-controlled clinical trial. The company noted that this is the sixth FDA approved indication for Actemra/RoActemra since the medicine was launched in the U.S. in 2010. For comments and feedback contact:
罗氏公司表示,FDA已经批准了Actemra/Roactemra皮下注射,用于减缓系统性硬化症相关间质性肺病成年患者肺功能下降的速度。Actemra/Roactemra是第一个被批准用于治疗该病的生物疗法。FDA的批准是基于focuSSced试验的数据,这是一项三期随机、双盲、安慰剂对照的临床试验。 该公司指出,这是自2010年Actemra/Roactemra在美国上市以来,FDA批准的第六个Actemra/Roactemra适应症。 如需评论和反馈,请联系