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Roche: FDA grants breakthrough therapy for Esbriet

(CercleFinance.com) - Swiss drugmaker Roche on Tuesday said that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Esbriet for adults with unclassifiable interstitial lung disease.


Unclassifiable interstitial lung disease (uILD) describes a diverse group of over 200 types of rare pulmonary diseases that share similar features, including coughing and shortness of breath.

Breakthrough therapy designation is given to accelerate the review of medicines intended to treat serious and life-threatening conditions with evidence that indicates they may demonstrate a substantial improvement over already existing therapies.

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