Regulatory Decision Summary for Lorcaserin hydrochloride (*Belviq)

Decision issued

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

Date of cancellation

2018-02-02

What was the purpose of this submission?

The purpose of this New Drug Submission was to obtain market authorization for lorcaserin hydrochloride as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m² or greater (obese), or 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, type 2 diabetes).

What did the company submit to supports its submission?

The sponsor submitted drug quality, pre-clinical and clinical components. The pivotal clinical safety and efficacy information consisted of the following: three Phase III studies, two of which were in obese patients without Type 2 Diabetes (BLOOM and BLOSSOM) and a Phase III trial in adults with type 2 diabetes (BLOOM-DM).

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, the review of the submission was nearing completion. Health Canada had identified some open questions about the data that would have precluded issuing an approval. Eisai could not address the questions and decided to withdraw the 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:
Belviq

Manufacturer
Eisai Limited.

Drug Identification Numbers issued
N/A

Date filed
2016/09/27