dm+d

17362111000001104

New Medicines

ElonvaHypogonadotropic hypogonadism - in combination with human chorionic gonadotropin

Information

Elonva
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Phase III Clinical Trials
Recommended for approval (Positive opinion)
None
Apr 22EU positive opinion granted recommending a license change to include use for the treatment of hypogonadotropic hypogonadism. The proposed new indication is ‘Elonva is indicated for the treatment of adolescent males (14 years and older) with hypogonadotropic hypogonadism, in combination with human Chorionic Gonadotropin (hCG)’ [8].
Mar 21EMA recommend submission of type II variation to update product information with results of PIII trial (NCT03019575) [6].
Oct 20Merck submit results of PIII NCT03019575 to EMA as part of an agreed Paediatric Investigation Plan [6].

Category

Long-acting version of follicle-stimulating hormone (FSH)
Hypogonadotropic hypogonadism can be congenital or acquired. Congenital hypogonadotropic hypogonadism is divided into anosmic hypogonadotropic hypogonadism (Kallmann syndrome) and congenital normosmic isolated hypogonadotropic hypogonadism (idiopathic hypogonadotropic hypogonadism). Incidence of congenital hypogonadotropic hypogonadism is approximately 1-10 per 100,000 live births [1].
Hypogonadotropic hypogonadism - in combination with human chorionic gonadotropin
Subcutaneous injection

Trial or other data

May 20PIII NCT03019575 trial completes [5].
Nov 19Estimated primary completion date of NCT03019575 is April 20 [4].
Jan 19PIII study (NCT03019575) is no longer recruiting [3].
Mar 17Results of PIII NCT01709331 trial (n=23) are published in Reproductive Biology and Endocrinology. After 16 weeks pre-treatment with human chorionic gonadotropin (hCG) alone, 18 subjects with normalised testosterone levels who remained azoospermic entered a 52-week combined treatment phase with hCG twice-weekly and 150 μg corifollitropin alfa every other week. Combined treatment resulted in a mean testicular volume increase from 8.6ml to 17.8ml (primary endpoint). No subject developed confirmed anti-corifollitropin alfa antibodies during the trial [7].
Feb 17PIII trial to investigate the safety and efficacy corifollitropin alfa in combination with human chorionic gonadotropin for initiation or restoration of puberty as assessed by increased testicular volume in adolescent males (aged 14 to 17 years) with hypogonadotropic hypogonadism starts (NCT03019575). The trial will enrol approximately 15 patients in Brazil, Denmark, Italy, Mexico, South Africa & Russia. Collection of primary outcome data (percentage change from baseline in Log-Transformed Testicular Volume at Week 64, percentage of participants with adverse events, & anti-corifollitropin alfa antibodies up to week 65) is expected to complete May 20 [3].
Apr 15PIII study to evaluate the efficacy and safety of corifollitropin alfa in combination with chorionic gonadotropin in men with hypogonadism who remain azoospermic when treated with chorionic gonadotropin alone completes (NCT01709331). The trial enrolled 18 patients in Australia, the UK, Finland, Germany, Italy, Poland and Spain [2].