Roche: FDA grants priority review To Esbriet
(CercleFinance.com) - Roche has received priority review status from the Food and Drug Administration for its treatment of unclassifiable interstitial lung disease (UILD), the Swiss drugmaker said on Thursday.
In a statement this morning, the healthcare company said it expects the decision for its Esbriet tablets to come by the month of May.
In pulmonary care, unclassifiable interstitial lung disease describes cases that defy classification following medical examinations from several specialists.
How Esbriet - which is already approved in the US for patients with idiopathic pulmonary fibrosis - works is still not yet fully understood, although the drug may reduce inflammation and fibrosis in lungs.
FDA's priority designation is given to drugs that address unmet medical needs in the treatment of serious or life-threatening conditions.
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