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Merck's Follicle Stimulent Elonva Granted European Commission Approval - Update

By RTTNews Staff Writer   ✉  | Published:  | Google News Follow Us  | Join Us
rttnewslogo20mar2024

Drug major Merck & Co., Inc. (MRK) Thursday said the European Commission has approved its controlled ovarian stimulant injection Elonva for multiple follicle development in women participating in assisted reproductive technology program. The injection is indicated in combination with a GnRH antagonist. The company noted that the approval would give it marketing authorization for the drug with unified labeling valid in all European Union Member States.

The Whitehouse Station, New Jersey-based company said Elonva may reduce the burden of injections for women undergoing fertility treatment, as it can initiate and sustain multiple follicular growth for an entire week with a single subcutaneous injection. Currently seven injections on a daily basis are required for preparation in a controlled ovarian stimulation treatment cycle.

Elonva's phase III trial showed that the primary ongoing pregnancy rate obtained in the Elonva treatment arm was similar to that achieved in patients receiving a daily dose of follicle stimulating hormone.

The company said the most frequently reported adverse drug reactions during treatment with Elonva are Ovarian Hyperstimulation Syndrome, pelvic pain and discomfort, headache, nausea, fatigue and breast complaints.

In Wednesday's regular trading session, MRK closed trading at 38.64 per share on the New YorkStock Exchange. In the past 52-week range, shares have been trading in the range of $20.05 to $41.56.

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