European approval for Merck & Co's Elonva and new indication for Roche's Herceptin; Roche sets up Singapore research hub

The European Commission has approved US drug giant Merck & Co's Elonva (corifollitropin alfa injection) 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, the company noted. 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 the drug 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.