Merck (MRK) announced that the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Elonva (corifollitropin alfa injection). Merck is seeking the drug’s approval as a treatment in controlled ovarian stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women who have participated in an assisted reproductive technology (ART) program. On European Commission’s approval, Merck would be able to market Elonva with unified labeling valid in all European Union Member States.

Elonva is the first in a class of sustained follicle stimulants (SFS). It scores better than the current available treatment option − a single subcutaneous injection of Elonva is likely to replace the first seven injections of any daily recombinant follicle stimulating hormone (rFSH) preparation in a COS treatment cycle.

The positive opinion of the committee is based on data from Elonva’s phase III development program, the Engage trial, which is the largest double-blind fertility agent trial ever performed. The data was quite encouraging for Elonva. The primary endpoint of the trial, the ongoing pregnancy rate (assessed at ten weeks or more after embryo transfer), for Elonva treatment arm was similar to the patients receiving a daily dose of rFSH for seven days (38.9% vs 38.1% per started cycle respectively).

The fertility industry is worth an estimated £500 million (approximately $820 million) a year in the UK. We believe a positive opinion from the committee has increased the probability of final approval. Viewing the potential of the market, we expect Elonva to add value to Merck’s current product portfolio. We have a Neutral recommendation on Merck.

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