Regulatory Decision Summary for Olumiant

Decision issued

No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.

Date of cancellation

January 28, 2022

What was the purpose of this submission?

This Supplement to a New Drug Submission (SNDS) for Olumiant (baricitinib) was filed to obtain market authorization for the indication of atopic dermatitis (AD) in adults with moderate to severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Currently, Olumiant 2 milligram (mg) oral tablets, once daily, is indicated in combination with methotrexate (MTX), for reducing the signs and symptoms of moderate to severe rheumatoid arthritis (RA), in adult patients who have responded inadequately to one or more disease-modifying anti-rheumatic drugs (DMARDs). Olumiant may also be used as monotherapy in cases of intolerance to MTX.

What did the company submit to support its submission?

The sponsor submitted eight clinical studies, from which three randomized, double-blind, phase III, placebo-controlled trials were considered pivotal to support the safety and efficacy of Olumiant.

What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?

At the time of the cancellation, Health Canada had identified some potential safety concerns related to increased risk of serious heart-related events such as heart attack or stroke, cancer, blood clots, and death. Following discussions with the sponsor regarding the proposed indication and identified safety concerns, the sponsor chose to cancel their submission.

What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?

There is no expected impact for patients using SAP or in clinical trials.

Additional information

*Proposed Brand Name:

Olumiant