Positive Opinion for Merck Drug – Analyst Blog
Zacks Market Commentaries (November 23rd, 2009) Writes:
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,
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