部分中文Elonva处方资料（仅供参考）

促排卵药Elonva已通过欧盟批准
默沙东促排卵药Elonva(corifollitropin alfa注射剂)已通过欧盟批准，该药与GnRH拮抗剂联用对患者进行控制性促排卵(COS)。它主要用于那些采用辅助生殖技术(ART)生育的妇女，促进其卵泡发育。随着Elonva在欧盟地区获准，默克将可以在所有欧盟成员国推出这种产品，并采用统一标签。
Elonva可持续一周促进患者多个卵泡发育。默克表示，在COS治疗周期之初，若采用常规重组卵泡刺激素(rFSH)治疗，在头7天需每天注射一次药物，而仅注射1剂Elonva就可以达到7剂rFSH的效果。
Elonva的III期临床实验当中，有一项名为Engage的实验是迄今为止规模最大的针对治疗不孕症的试管婴儿临床实验项目。实验结果显示，Elonva受试组当中，患者在每一个治疗周期的受孕几率(实验主要终点)可达到38.9%，与使用rFSH的对照组效果相当，后者每一治疗周期受孕率为38.1%。
默克研发实验室负责人米杰姆·莫尔·艾特斯表示：“Elonva在欧盟地区获准上市后，当地的不孕症妇女将可免去频繁注射促排卵药的困扰。默克将会再接再厉，致力于研发以患者为本的不孕症治疗药。”
Merck Receives European Approval for ELONVA? (corifollitropin alfa injection)
Merck & Co., Inc., which operates outside the U.S. and Canada as MSD, today announced the European Commission (EC) approval of ELONVA? (corifollitropin alfa injection). ELONVA is indicated for controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an assisted reproductive technology (ART) program.
With the EC approval, Merck receives marketing authorization for ELONVA with unified labeling valid in all European Union Member States.
Schering-Plough Corp. and Merck & Co., Inc. merged on Nov. 3, 2009.
ELONVA is the first sustained follicle stimulant. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any conventional daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.
"The European approval of ELONVA is a positive step towards reducing the burden of injections for women experiencing difficulty conceiving," said Mirjam Mol-Arts, senior vice president, Merck Research Laboratories.
"Merck is proud of the company's women's health portfolio and is committed to providing effective patient-focused fertility treatments."
The Phase III development program for ELONVA included the Engage trial, the largest double-blind fertility agent trial in IVF performed to date. In the Engage trial, the ongoing pregnancy rate, the primary endpoint, obtained in the ELONVA treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1 percent per started cycle).
(1) The most frequently reported adverse drug reactions during treatment with ELONVA in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS) (5.2%), pelvic pain (4.1%) and discomfort (5.5%), headache (3.2%), nausea (1.7%), fatigue (1.4%) and breast complaints (including tenderness) (1.2%).
Use with GnRH agonists is not recommended.
About ELONVA
ELONVA is approved for COS in combination with a GnRH antagonist for the development of multiple follicles in women participating in an ART program.
ELONVA is designed as a sustained follicle stimulant with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration of FSH activity.
Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of ELONVA may replace the first seven injections of any daily rFSH preparation in a COS treatment cycle.
About Engage
Engage was a non-inferiority trial designed to compare ELONVA 150 mcg to 200 IU rFSH. A total of 1,506 patients (with a body weight greater than 60 kg) at 34 in-vitro fertilization (IVF) clinics in North America and Europe were randomized to start stimulation with either ELONVA 150 mcg or a daily dose of 200 IU rFSH for seven days. Patients also received rFSH (maximum 200 IU/day) from stimulation day eight onward, when required.
Starting on stimulation day five, all patients received 0.25mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG).
The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer.
In the ELONVA treatment arm the ongoing pregnancy rate (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of rFSH (38.1 percent per started cycle).
(1) The number of oocytes retrieved per attempt, the co-primary endpoint, was 13.7 (± 8.2) for the ELONVA group and 12.5 (± 6.7) for the rFSH group.(1) About InfertilityInfertility is a disease or condition that impairs the body's ability to perform the basic function of reproduction.
(2) It is often diagnosed after a couple has not conceived after one year of unprotected, well-timed intercourse.
(3) Women over the age of 35 are encouraged to seek diagnosis and treatment for infertility following six months of unprotected intercourse.
(4) Around 15 percent of couples of reproductive age have a fertility problem.
(5) There are many causes of infertility including problems with the production of sperm or eggs, with the fallopian tubes or the uterus, endometriosis, frequent miscarriage, as well as hormonal and autoimmune (antibody) disorders in both men and women.
(6) With infertile couples, the source of infertility lies with the male in 40 percent of cases and 40 percent with the female.
The remaining 20 percent is either a joint problem or unknown, because the cause has not been identified.
There are a variety of treatments available for infertility; these include surgery, hormone treatments, insemination and IVF, among others.
(7) About Merck
Today's Merck is working to help the world be well. Through our medicines, vaccines, biologic therapies, and consumer and animal products, we work with customers and operate in more than 140 countries to deliver innovative health solutions.
We also demonstrate our commitment to increasing access to health care through far-reaching programs that donate and deliver our products to the people who need them. Merck. Be Well. For more information, visit www.merck.com.

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产地国家: 英国
原产地英文商品名:
ELONVA SOLUTION FOR INJECTION
原产地英文药品名:
CORIFOLLITROPIN ALFA
中文参考商品译名:
ELONVA注射用溶液剂
中文参考药品译名:
CORIFOLLITROPIN ALFA
生产厂家中文参考译名:
默克
生产厂家英文名:
Merck