March 3, 2020 / 6:14 AM / a month ago

BRIEF-FDA Grants Roche's Genentech Breakthrough Therapy Designation For Esbriet

March 3 (Reuters) - Genentech, a member of the Roche Group :

* FDA GRANTS BREAKTHROUGH THERAPY DESIGNATION FOR GENENTECH’S ESBRIET (PIRFENIDONE) IN UNCLASSIFIABLE INTERSTITIAL LUNG DISEASE

* THERE ARE CURRENTLY NO FDA-APPROVED TREATMENTS FOR UNCLASSIFIABLE ILD (UILD), A DEBILITATING, SEVERE RESPIRATORY CONDITION

* DESIGNATION IS BASED ON RESULTS FROM A PHASE II TRIAL, WHICH SUGGESTED ESBRIET SLOWED DISEASE PROGRESSION IN PATIENTS WITH UILD AT 24 WEEKS

* GENENTECH, A MEMBER OF ROCHE GROUP ANNOUNCED THAT U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS GRANTED BREAKTHROUGH THERAPY DESIGNATION TO ESBRIET® (PIRFENIDONE) FOR ADULTS WITH UNCLASSIFIABLE INTERSTITIAL LUNG DISEASE (UILD) Source text for Eikon: [tinyurl.com/wmt3qth] Further company coverage: (Berlin Speed Desk)

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