Roche’s Actemra/RoActemra therapy, intended for slowing the rate of decline in pulmonary function for adults with systemic sclerosis-associated interstitial lung disease, has been approved by the FDA.
The treatment is the first biologic therapy endorsed by the North American agency for the rare lung condition.
Approval comes after positive results in the Phase III focuSSced trial, a placebo-controlled trial of 212 adults with systemic sclerosis (SSc).
The study did not meet its primary endpoint of change by week 48 in the modified Rodnan Skin Score, which measures scarring or hardening of the skin. However, patients treated with Actemra/RoActemra did still show less decline by week 48 in forced vital capacity, a measure of lung function that evaluates how much air can be exhaled.
SSc is an autoimmune disease that worsens over time and currently has no cure. It occurs when the immune system malfunctions causing tissues of the skin and lungs to thicken and harden.
Interstitial lung disease, which may occur in approximately 80% of the world’s 2.5 million SSc patients, causes inflammation and scarring of the lungs, and can be life-threatening.
Actemra/RoActemra is part of a co-development agreement with Chugai Pharmaceutical Co and has already been approved in more than 110 countries worldwide, including Japan since April 2005.
Dr Levi Garraway PhD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “We are honoured to offer the very first FDA-approved biologic treatment option to people living with systemic sclerosis-associated interstitial lung disease.
“We worked closely with the FDA to evaluate Actemra/RoActemra’s impact on lung function in this setting. This milestone approval provides a much-needed new treatment option for people living with this rare, debilitating disease.”
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