Mithra receives approval in France to market hormone replacement therapy Tibelia


Women's health specialist Mithra has received a marketing authorisation (MA) for the commercialisation of Tibelia in France.

Developed by the company, Tibelia is a synthetic steroid (tibolone) developed by the company for use in hormone replacement therapy.

The drug is a bioequivalent of 2.5mg of Livial, which is also developed by Mithra.

Livial mimics the activity of the female sex hormones in the body and is used particularly for the relief of symptoms occurring after menopause.

In addition to offering relief from post-menopausal symptoms, Tibelia also helps prevent osteoporosis in post-menopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products.

The indications represent a global market of €114.5m, which is equivalent to 299 million tablets sold each year.

"We expect Tibelia to become an increasingly important source of future revenue, especially as we transfer its production to our CDMO facility in the future."

Through existing supply and license agreements signed in last year, Mithra’s Tibelia is already being sold on the market in the UK, Spain and the Netherlands.

In addition, the treatment is expected to be launched in Italy, Finland and Sweden in the coming months.

This year, the company expects to sign further agreements, including in France.

Mithra plans to transfer the manufacturing of Tibelia to its research, development and production facility, Contract Development and Manufacturing Organisation (CDMO), in Liège, Belgium.

Mithra CEO François Fornieri said: “We are very pleased to receive MA for the commercialisation of Tibelia in France, the final country remaining under the European decentralised procedure.

“The MAs obtained underline once more the development and regulatory expertise of our dedicated teams here at Mithra.

"We expect Tibelia to become an increasingly important source of future revenue, especially as we transfer its production to our CDMO facility in the future.”