Roche 'pinot one" FDA awards breakthrough therapy title

On March 3, Roche's GeneTek announced that the FDA had awarded its Esbriet (psilocybin) breakthrough therapy designation for the treatment of adult patients with unclassified intersyterirosis disease (unclassifiable interstitial lung disease, uILD)Esbriet, the first FDA-approved drug to treat iacostosofa, was approved by the FDA in October 2014 and is currently available in more than 60 countries worldwideIn 2019, Esbriet's sales reached CHF 1,129 millioninterstitial pulmonary disease (ILD) is a group of diseases with pulmonary interstitial as the main lesions, the causes are diverse, with cough and post-active breathing difficulties as the main clinical manifestations, the disease often gradually worsens, and eventually leads to respiratory failureAlthough ILD is characterized by coughing and shortness of breath, the causes of each ILD patient are different and the treatment methods are differentIt is estimated that about 10% of ILD patients are not yet clearly diagnosed and are classified as uILDCurrently, the FDA has not approved any treatments for uILDthe award of breakthrough therapy is based on the results of a randomized, double-blind, placebo-controlled International Multicenter Phase II clinical trialWithin 24 weeks of treatment, the median force lung capacity (FVC) measured by the family lung capacity meter decreased by 87.7 mL (Q1-Q3 -338.1 to 148.6) and the placebo group decreased by 157.1 mL (-370.9 to 70.1)After 24 weeks of treatment, patients in the pyridoxonone group had a 95.3 mL lower FVC value than the placebo groupsafety, the most common therapeuticly related adverse reactions in the ketone group compared to placebo group were gastrointestinal disease (47 percent vs 26 percent), fatigue (13 percent vs 10 percent) and rash (10 percent vs 7 percent).