New analysis of Rekovelle® data further supports use of AMH to personalise fertility treatment

New analysis of Rekovelle® data further supports use of AMH to personalise fertility treatment

• Rekovelle’s unique dosing algorithm, which is based on a woman’s anti-Müllerian hormone (AMH) level and body weight, is designed for predictable ovarian response

• New analysis shows that natural variations in a woman’s AMH levels have no clinically relevant impact on ovarian response when using AMH to dose Rekovelle

• New analysis reinforces that AMH measured on any day of a woman’s menstrual cycle can be used to determine her daily dose of Rekovelle

Saint-Prex, Switzerland – 2 July, 2018 –

Ferring Pharmaceuticals announced today a new analysis* of data from the Phase 3 ESTHER-1 trial¹ showing that natural variations in anti-Müllerian hormone (AMH) levels during and between a woman’s menstrual cycle have no clinically relevant impact on ovarian response (the number of eggs produced) when using AMH to dose Rekovelle® (follitropin delta) for ovarian stimulation (OS).² The data were presented today at the 34th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Barcelona, Spain.

According to the new analysis, for 95% of women treated with Rekovelle, variations in ovarian response were limited to a difference of plus or minus one egg². This reinforces that AMH measured on any day of a woman’s menstrual cycle can be used to individualise the dose of Rekovelle. AMH is measured with a companion diagnostic, the Elecsys® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).

“We are excited to share the results of this new Rekovelle analysis which add to existing evidence showing AMH is a robust predictor of ovarian response to fertility treatment,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “I believe these data will further strengthen the growing confidence of doctors in the use of AMH to personalise dosing of fertility treatment for their patients.”

Ovarian response to stimulation varies considerably from woman to woman³ and unexpected extreme responses have implications on efficacy and safety.^4,5 Aiming to avoid extremes in ovarian response, the validated Rekovelle dosing algorithm uses AMH and body weight to determine a personalised dose for patients, from the start of treatment.

This analysis of data from the Phase 3 ESTHER-1 trial adds to consistent efficacy results seen with Rekovelle in clinical trials to date. The ESTHER-1 trial showed that women undergoing their first treatment cycle receiving individualised treatment with Rekovelle, compared to conventional dosing regimen with follitropin alfa,^1,‡§ had similar ongoing pregnancy and embryo implantation rates.¹

The ESTHER-1 trial also showed that more women receiving individualised treatment with Rekovelle achieved the target response of 8-14 eggs compared to conventional dosing regimen with follitropin alfa.1ठEvidence shows that beyond 15 eggs there is no additional benefit, in terms of live birth rate, in the number of eggs produced through OS in a fresh cycle.^6,7

About Rekovelle (follitropin delta)

Rekovelle is a human recombinant follicle stimulating hormone (rFSH) with an approved dosing algorithm designed for predictable ovarian response.⁸ It is the first rFSH derived from a human cell line (PER.C6^® cell line). Rekovelle is structurally and biochemically distinct from other existing rFSH gonadotrophins.^8,9 Rekovelle is approved for use in ovarian stimulation (OS) for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as an in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).⁸ The individualised dosing of Rekovelle is determined using an approved algorithm, based on a woman’s anti-Müllerian hormone (AMH) level and body weight.^1,8,10 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.¹¹ AMH will be measured with a companion diagnostic, the Elecsys^® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).^12,13

As of 15 June 2018, Rekovelle was approved in 37 countries and available in 17 countries worldwide.

About the ESTHER trials

The ESTHER trials (Evidence-based Stimulation Trial with Human recombinant FSH in Europe and Rest of World) were randomised, assessor-blind, controlled, multicentre Phase 3 trials involving patients in 11 countries and over 2,000 cycles of OS.^1,14

ESTHER-1 was a trial of 1,326 patients in 11 countries undergoing their first ART cycle. Patients were randomised 1:1 to receive treatment with individualised Rekovelle, a fixed daily dose based on serum AMH levels5 and body weight, or conventional follitropin alfa dosing.¹‡ The co-primary endpoints of ongoing pregnancy rates and ongoing implantation rates were met, demonstrating comparable efficacy of Rekovelle to conventional treatment.¹ Rekovelle’s individualised dosing regimen aims to obtain an ovarian response associated with a favourable safety/efficacy profile, i.e. aims to achieve an adequate number of eggs and reduce interventions to prevent ovarian hyperstimulation syndrome.⁸

ESTHER-2 evaluated the immunogenicity of Rekovelle in a subset of ESTHER-1 patients undergoing repeated cycles of OS for ART. Data demonstrated no increased immunogenicity risk with Rekovelle after exposure in repeated cycles.^8,14

About Ferring Pharmaceuticals

Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and women’s health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring now employs approximately 6,500 people worldwide, has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries.

Learn more at www.ferring.com, or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube.

About the Elecsys® AMH Plus immunoassay from Roche

he Elecsys^® AMH Plus immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.^{12,13,15,16,17,18} This fully automated Elecsys^® AMH Plus immunoassay, run on the cobas^® e and Elecsys^® immunoassay analysers, determines AMH levels in 18 minutes, making it appropriate for routine clinical use. The Elecsys^® AMH Plus immunoassay is intended to be used for assessment of ovarian reserve, prediction of response to OS and establishment of the individual daily dose of Ferring follitropin delta in combination with body weight in OS for the development of multiple follicles in women undergoing an assisted reproductive technology programme.^{8,12,15,17,18}

Footnotes

^* A sub-analysis of the ESTHER-1 study population including 1,326 women (aged 18-40 years). Serum AMH was measured at a random day at screening and at cycle day 2-3 prior to stimulation using the Elecsys^® AMH Plus immunoassay (Roche). Limitations: A centralised AMH measuring laboratory was used which may give rise to reduced AMH variability. AMH measurements were compared with samples taken within 3 months prior to ovarian stimulation, longer time intervals may have shown different variability due to the age-related decline in AMH.

^† GONAL-f^®, registered trademark of Merck KGaA, Darmstadt, Germany.

^‡ Conventional dosing of follitropin alfa is 150 IU/d for 5 days, with potential subsequent dose adjustments at a maximum of 450 IU/d.¹

^§ ESTHER-1 was neither designed nor powered to assess results based on secondary endpoints. Predefined secondary endpoints are used as a measurement to yield supportive evidence to evaluate additional effects relevant to informing the Rekovelle individualised dosing regimen. No confirmatory conclusions can be derived.

^** AMH is measured by a companion diagnostic, the Elecsys^® AMH Plus immunoassay from F. Hoffmann-La Roche Ltd (Roche).

– ENDS –

For more information, please contact:

Bhavin Vaid
Head of Corporate Communications
+41 58 301 09 52 (direct)
+41 79 191 06 32 (mobile)
bhavin.vaid@ferring.com

Lindsey Rodger
Senior Manager, Corporate Communications
+41 58 451 40 23 (direct)
+41 79 191 04 86 (mobile)
lindsey.rodger@ferring.com

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