Regulatory Decision Summary for ESBRIET
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
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What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission (SNDS) was to broaden the indication to all idiophathic pulmonary fibrosis (IPF) patients from the current indication that limits the use of pirfenidone to patients diagnosed with mild to moderate IPF.
Why was the decision issued?
The Study PIPF-016 compared treatment with Esbriet 2403 mg/day to placebo. 555 patients were enrolled in this study (278 pirfenidone, 277 placebo), including 435 male and 120 female patients with an overall mean age of 68.1 years and comprising 506 whites, 33 American Indian or Alaskan natives, and 16 persons of other races. Treatment was administered three-times daily for 52 weeks. The primary endpoint was the change from Baseline to Week 52 in the percent predicted Forced Vital Capacity (FVC). In Study PIPF 016, the decline of percent-predicted FVC from Baseline at Week 52 of treatment was significantly reduced in patients receiving Esbriet compared with patients receiving placebo.
The safety of Esbriet has been evaluated in more than 1,400 subjects with over 170 subjects exposed to pirfenidone for more than 5 years in clinical trials. The most common adverse reactions (≥10%) were nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastro-esophageal reflux disease, sinusitis, insomnia, weight decreased, and arthralgia.
Idiophathic pulmonary fibrosis is a rare, invariably fatal disease of unknown etiology that is characterized by progressive fibrosis of the lung interstitium. Currently, Esbriet (pirfenidone) and nintedanib are the only approved or marketed therapies for the treatment of IPF in Canada. Keeping in mind the severity of the disease and the limited treatment options available, the broadening of the indication for Esbriet to include all IPF patients would avoid depriving IPF patients who may potentially benefit from pirfenidone use and are currently excluded from a limited indication.
The modification to the Adverse Reactions and Clinical Trials sections of the Product Monograph do not alter the benefit-harm-uncertainty assessment of Esbriet and its use remains favorable for the newly expanded indication.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.