September 28, 2018 / 9:48 PM / 3 months ago

Insmed's treatment-resistant lung disease drug gets FDA approval

Sept 28 (Reuters) - The U.S. Food and Drug Administration on Friday approved Insmed Inc’s lead drug to treat a rare, chronic lung disease, making it the first approved treatment in the United States for the condition.

The drug’s label contains a boxed warning - the FDA’s strictest — of increased risk of respiratory conditions, including inflamed lungs and spitting up blood.

The approval was largely expected and follows the agency’s advisory committee backing the drug, Arikayce (amikacin liposome inhalation suspension), in a meeting in early August. (Reporting by Saumya Sibi Joseph and Shanti S nair in Bengaluru; Editing by Maju Samuel)

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