Forex News
Health Canada Accepts Knight's GEMTESA Submission
Health Canada accepted Knight Therapeutics' New Drug Submission for GEMTESA, its overactive bladder treatment already marketed in the US.
- Health Canada accepted Knight Therapeutics' New Drug Submission for GEMTESA for review.
- Overactive bladder affects approximately 20% of people globally.
- Up to 80% of men with OAB linked to BPH remain undiagnosed.
- Knight Therapeutics trades as GUD on the Toronto Stock Exchange.
- In the COURAGE trial, 965 of 1,105 participants, or 87.3%, completed the study.
Submission and Partner
Health Canada accepted for review Knight Therapeutics' New Drug Submission for GEMTESA. The GEMTESA trademark is owned by Sumitomo Pharma Co., Ltd., and Knight's partner on the product is Sumitomo Pharma America Inc.. GEMTESA is already marketed in the US for OAB treatment.
The acceptance of our submission for GEMTESA® in Canada is an important step toward bringing this therapy to the patients who need it.
— Samira Sakhia, President and Chief Executive Officer, Knight Therapeutics Inc.
Mechanism and Trial Data
GEMTESA selectively targets β3 adrenergic receptors to reduce OAB symptoms. The EMPOWUR trial, a 12-week, double-blind, placebo-controlled Phase 3 study, evaluated vibegron 75 mg versus placebo. It produced statistically significant reductions in daily urgency urinary incontinence, micturition and urgency episodes, and an increase in volume voided versus placebo. Common adverse reactions included headache, nasopharyngitis, diarrhea, nausea and upper respiratory tract infection.
The COURAGE trial randomized 1,105 participants, of whom 965, or 87.3%, completed the study. It met secondary endpoints, showing significant reductions in nocturia and urgency urinary incontinence episodes versus placebo. Common adverse events included hypertension, COVID-19, urinary tract infection and hematuria. The trial is registered under identifiers NCT03902080 and URO-901-3005.
Market Context
Overactive bladder affects approximately 20% of people globally. Canadian prevalence ranges from approximately 14% to 18%. BPH affects approximately 14 million men in the US, and detrusor overactivity occurs in about 20% to 40% of men with BPH. Up to 80% of men with OAB linked to BPH remain undiagnosed. The EPIC study found storage symptom prevalence of 51.3% among men.
Company Profile
Knight Therapeutics is a pan-American, ex-US pharmaceutical company headquartered in Montreal, Canada. Its Latin American subsidiaries include United Medical, Biotoscana Farma and Laboratorio LKM. The company trades as GUD on the Toronto Stock Exchange.