Ferring用于接受辅助生育手术后的妇女控制卵巢刺激的药物Rekovelle 已获得欧洲监管机构批准。
该公司称，Rekovelle（follitropin delta）是第一个从人体细胞衍生的重组促卵泡激素（rFSH），是第一个基于女性血清抗米勒利安激素水平（AMH，用于评估卵巢储备的生物标志物）及体重制定个体化给药方案的 rFSH 药物。
该药物的批准决定是基于3期ESTHER试验的结果，数据显示，与常规rFSH 药物（follitropinα）相比，Rekovelle的个体化治疗对于持续怀孕率和持续着床率两个共同主要终点具有相似的结果。
采用Ferring的药物治疗的患者也比那些接受常规 rFSH 药物治疗的患者更容易达到最佳卵母细胞产量（8-14 个卵母细胞），并且极少出现临床相关的卵巢过度或低反应，而卵巢过度刺激综合征（OHSS）和/或 OHSS 干预治疗很少出现，该公司指出。
Rekovelle的个性化给药方案为医生提供了一种基于 AMH（一种高度预测性生物标志物）进行个性化治疗的一致，循证的新方法，ESTHER 试验的首席研究员 Andersen 教授表示。使用经过验证的个性化治疗方案可以帮助医生在确保疗效的同时减少治疗期间的并发症，为患者提供最佳的治疗结果。
Ferring receives acceptance of Marketing Authorisation filing from EMA for personalised fertility treatment with REKOVELLE® (follitropin delta)
Saint-Prex, Switzerland, 30 October 2015 – Ferring Pharmaceuticals announced today that the filing for the Marketing Authorisation Application for REKOVELLE® (follitropin delta) has been accepted for review by the European Medicines Agency (EMA). REKOVELLE is a novel human recombinant follicle-stimulating hormone (rhFSH) intended for controlled ovarian stimulation (COS) in women undergoing assisted reproductive technology (ART) therapy such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).1-3 The submission is supported by comprehensive data from the Phase 3 ESTHER trials (Evidence-based Stimulation Trial with Human rFSH in Europe and Rest of World) involving 1,326 patients from 37 fertility clinics in 11 countries.
If approved, REKOVELLE would be administered in an individualised dosing regimen according to both the measurement of the woman’s serum anti-Müllerian hormone (AMH), a biomarker that assesses ovarian reserve and predicts ovarian response to stimulation, as well as her body weight. Fertility specialists would assess each patient’s biomarker profile and characteristics, and prescribe a precise fixed daily dose of REKOVELLE from the start of stimulation. This approach of controlled ovarian stimulation with an individualised REKOVELLE dosing regimen was prospectively studied in the ESTHER-1 trial.2 If approved, REKOVELLE would be paired with the recently launched fully-automated Elecsys® AMH immunoassay from Roche.
Personalised treatment is a new approach to the management of fertility treatment, with the ultimate goal of helping couples to conceive in an efficient and safe manner.
“Ferring Pharmaceuticals has a long heritage in reproductive health and the acceptance of the Marketing Authorisation Application filing for REKOVELLE in controlled ovarian stimulation represents our commitment to innovation and advancing the role of personalised medicine in the area of fertility,” commented Per Falk, MD, PhD, Executive Vice President and Chief Scientific Officer, Ferring.
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About REKOVELLE (follitropin delta)
REKOVELLE (also known as FE 999049) is the first human recombinant follicle stimulating hormone derived from a human cell line that has been developed for individualised dosing using a companion anti-Müllerian hormone (AMH) diagnostic immunoassay.2 REKOVELLE is a New Molecular Entity (NME) which is clinically distinct1,9 from other follitropins and is not a biosimilar.
About Ferring Pharmaceuticals
Headquartered in Switzerland, Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group active in global markets. The company identifies, develops and markets innovative products in the areas of reproductive health, urology, gastroenterology, endocrinology and orthopaedics. Ferring has its own operating subsidiaries in nearly 60 countries and markets its products in 110 countries. To learn more about Ferring or its products please visit www.ferring.com.
About the Elecsys® AMH immunoassay from Roche
The Elecsys® AMH immunoassay from Roche has been shown to provide a precise, reliable and robust measurement of AMH levels.10-15 The fully automated Elecsys® AMH immunoassay determines AMH levels in 18 minutes, making it appropriate for routine clinical use and providing clinical confidence in the reliable assessment of ovarian reserve. |
