Merck Receives European Approval for ELONVA® (corifollitropin alfa injection)

PharmaNews.eu

February 15, 2010

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.

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Hmm…- interesting to note that hundreds if not thousands of girls adversely affected by Gardasil – do not ovulate – their menstrual cycles suppressed.  One mother commented that she is afraid her daughter is going into menopause at age 21.

And now Merck is coming out with an injection to stimulate ovulation?  I would never take an injection from Merck or anyone else to stimulate ovulation especially if it was their initial injection (vaccine) that caused it to stop.

PG

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.