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FDA Approves First Biologic for Rare, Debilitating Lung Disease

Published: Mar 05, 2021 By Mark Terry Michael Vi/Shutterstock The U.S. Food and Drug Administration (FDA)approvedGenentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD). It is the first biologic approved by the FDA for this indication. Systemic sclerosis (SSc) is also called scleroderma. It is an autoimmune disease that progressively worsens. There is no cure. It is caused by the immune system malfunctioning, causing skin and lung tissues to thicken and harden. It affects up to 75,000 people in the U.S. Interstitial lung disease (ILD) occurs in about 80% of SSc patients, causing inflammation and scarring of the lungs. It can be life-threatening.

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