NGENLA (somatrogon) - Hormone de croissance

Key points

Approval of reimbursement in the treatment of children and adolescents aged three years and over with growth disorders due to insufficient secretion of growth hormone.

Therapeutic improvement?

No therapeutic improvement in relation to management.

Role in therapeutic strategy?

The initiation of treatment for GHD (growth hormone deficiency) requires three conditions to be met:

• A diagnosis of GH deficiency duly proven by appropriate investigations;
• Size ≤ - 2 SDS according to the French reference data;
• Growth rate in the past year below normal for age (-1 SDS) or < 4 cm/year.

The search for an organic cause of the deficit (hypophyseal MRI or CT scan) and possible associated pituitary deficits is an important step in the initial management of the patient.

Treatment follow-up

Non-responders exist but can only be identified by follow-up (no predictive factors).

Children treated with recombinant human growth hormone (rhGH) are seen in consultation every three months to clinically assess the efficacy of rhGH and any adverse effects. Once a year, the specialist should reassess the value of continuing the treatment. In order to conclude that the treatment was effective, the growth gain after the first year of treatment must have been at least 2 cm compared to the year before treatment. In the following years, the growth rate should be at least equal to the average for chronological age and/or bone age, and better than before treatment.

Treatment should be permanently discontinued:

• in case of the onset or progression of a tumoural process;
• in the event of the inefficacy of treatment: growth rate under treatment less than 3 cm/year irrespective of age, after the first year;
• when epiphyseal closure occurs, as revealed by X-rays.

When the somatotropic deficit is secondary to an intracranial lesion, regular investigations should be carried out in collaboration with the oncologists or neurosurgeons in order to detect any progression or relapse.

NGENLA (somatrogon) is a first-line medicinal product for the management of a growth disorder due to a GHD in children aged 3 to 18 years. This is a new treatment option compared to daily rhGH injections.