Health Canada has accepted a marketing authorisation application for the Belgian pharmaceutical company Mithra’s complex therapeutic Tibelia, a tibolone-based product, to be used in hormone therapy (HT).
There are currently no tibolone-based products available in the Canadian market to be used for the relief of postmenopausal symptoms and prevention of osteoporosis in post-menopausal women.
Tibelia, if approved, will be introduced in the country as a new treatment option for these indications.
With the acceptance of the marketing application for Tibelia, the company is on track to receive potential approval for the therapy in the fourth quarter of next year.
Mithra chief executive officer François Fornieri said: “We are very pleased to see Tibelia, which could offer women new options to safely address menopausal symptoms, continue to advance globally.
“Today’s news reconfirms that we are on track for a marketing authorisation decision in Canada as of late 2018, and we look forward to launching Tibelia on the Canadian market with our distribution partner.
“With Tibelia on the market in three countries already, and launches in Sweden and Finland planned this year, we expect that Canada will be an important contributor to the growing revenues of this product.”
In June this year, the company confirmed an exclusive licence and supply agreement for the tibolone-based treatment with an undisclosed Canadian partner.
The company is specialised in Women’s Health, with a special focus on fertility, contraception and menopause.