Somapacitan

Unassigned

New Medicines

Sogroya Growth hormone deficiency in adults

Information

Sogroya
New formulation
Novo Nordisk
Novo Nordisk

Development and Regulatory status

Phase III Clinical Trials
Recommended for approval (Positive opinion)
Approved (Licensed)
Jan 21Recommended for EU approval by CHMP - the full indication is "for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD)." It should be prescribed by physicians experienced in the diagnosis and treatment of adult patients with growth hormone deficiency (e.g. endocrinologists) [11].
Sep 20The first weekly therapy for adult growth hormone deficiency (GHD) approved in the US [10].
Sep 19Filed in EU via centralised procedure [9].
Mar 17Will be filed in the EU via the centralised procedure [2].

Category

A long-acting human growth hormone derivative, designed for once-weekly administration. It is derived from human growth hormone and is conjugated with an albumin binding moiety.
Adult GH deficiency has been estimated to affect 1 in 100,000 people annually, while its incidence rate is approximately 2 cases per 100,000 population when childhood-onset GH deficiency patients are considered. About 15-20 % of the cases represent the transition of childhood GH deficiency into adulthood [3].
Growth hormone deficiency in adults
Subcutaneous

Trial or other data

Nov 18PIII REAL 1 trial NCT02229851 completed Jul 18 [6]. A further two PIII studies (REAL 4 and REAL 5) are planned [7].
Mar 17Novo Nordisk initiates a PIII trial to evaluate the safety of once weekly dosing of somapacitan and daily Norditropin® FlexPro® for the treatment of previously human growth hormone treated patients with growth hormone deficiency (NN8640-4244; NCT03075644). This randomised, open-label, parallel-group, active controlled trial is enrolling 60 patients in Japan [1].
Feb 15Novo Nordisk starts the PIII REAL 2 study to evaluate the safety of once-weekly somapacitan versus once-daily somatropin (Norditropin FlexPro®), in adults with growth hormone deficiency who were previously treated with daily human growth hormone (NN8640-4043; NCT02382939). The primary endpoint is the incidence of adverse events, assessed from baseline to week 26. The study will enrol approximately 90 patients in Denmark, France, Germany, Japan, Sweden and the UK [1,2].
Oct 14Novo Nordisk initiates the PIII REAL 1 trial to assess the efficacy of once-weekly subcutaneous doses of somapacitan, compared to once-daily doses of somatropin, in adult patients with growth hormone deficiency (NN8640-4054; NCT02229851). The randomised, double-blind, placebo-controlled trial is intended to enrol 280 patients in the US, Australia, Brazil, Germany, India, Israel, Japan, Latvia, Lithuania, Malaysia, Norway, Poland, Romania, Russia, South Africa, Turkey, Sweden, Ukraine and the UK [1].

Sogroya Growth hormone deficiency in pre-pubertal children

Information

Sogroya
Licence extension / variation
Novo Nordisk
Novo Nordisk

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A long-acting human growth hormone derivative, designed for once-weekly administration. It is derived from human growth hormone and is conjugated with an albumin bidning moiety.
Adult GH deficiency has been estimated to affect 1 in 100,000 people annually, while its incidence rate is approximately 2 cases per 100,000 population when childhood-onset GH deficiency patients are considered. About 15-20 % of the cases represent the transition of childhood GH deficiency into adulthood [1].
Growth hormone deficiency in pre-pubertal children
Subcutaneous injection