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Home Industry News Ferring Pharmaceuticals’ Rekovelle recommended for EU approval

Ferring Pharmaceuticals’ Rekovelle recommended for EU approval

17th October 2016

Ferring Pharmaceuticals has announced that its new fertility treatment Rekovelle has won a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP).

The European Medicines Agency committee has endorsed the treatment for use in controlled ovarian stimulation for the development of multiple follicles in women undergoing assisted reproductive technologies, such as in vitro fertilisation or intracytoplasmic sperm injection cycles.

A comprehensive clinical development programme involving 1,326 patients in 11 countries and more than 2,000 cycles of controlled ovarian stimulation has demonstrated the effectiveness of this treatment.

If approved, Rekovelle would be administered using an individualised dosing regimen according to a woman's serum anti-Mullerian hormone (AMH) level and body weight. AMH is a biomarker used to assess ovarian reserves, and predict which patients may be at higher risk of experiencing reduced efficacy or increased safety concerns.

AMH would be measured through the use of a companion diagnostic tool, the Elecsys AMH Plus immunoassay, which was developed by Roche.

Dr Per Falk, chief scientific officer and executive vice-president at Ferring Pharmaceuticals, said: "If approved, this would be the first pairing of a drug with a companion diagnostic for individualised dosing in reproductive medicine."

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