Regulatory Decision Summary for Incruse Ellipta

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.


Product type:

Drug

Medicinal ingredient(s):

umeclidinium bromide

Therapeutic area:

Drugs for Obstructive Airway Diseases

Type of submission:

Supplement to a New Drug Submission

Control number:

222505
What was the purpose of this submission?

 

The sponsor filed this Supplement to a New Drug Submission (SNDS) for the following:

  • To propose updates to the Indications and Clinical Use, Adverse Reactions, Clinical Trials and Part III: Consumer Information sections of the Incruse Ellipta Product Monograph (PM), based on data from studies CTT116855 and DB2113373.
  • To propose the addition of the following bolded text in the indication: Indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction and for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

 

Why was the decision issued?

 

Incruse Ellipta (umeclidinium) is a long-acting muscarinic antagonist indicated for the long-term once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Following discussion with Health Canada during the course of the submission, the Sponsor withdrew the proposed modification to the indication.

Information and text from study CT116855 currently found in the Trelegy Ellipta PM (a triple therapy containing the active ingredient of Incruse Ellipta) was considered acceptable to be added to the PM of Incruse Ellipta, to recognize the effects of umeclidinium on exacerbations, as part of a triple combination. However, the inclusion of data from study DB2113373 was not possible as it was not designed to evaluate the effect of treatments on COPD exacerbations. These design issues consisted of, among others, study duration, sample size, statistical hierarchy, and COPD exacerbation as an Other Efficacy Endpoint. Along with the inferences that have been drawn from the study analyses, data from study DB2113373 were not included in the PM.

The modification to the Clinical Trials section of the PM does not alter the benefit-harm-uncertainty assessment of Incruse Ellipta and its use remains favorable for the approved indication.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.