Sogroya
Authorised
This medicine is authorised for use in the European Union
somapacitan
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Sogroya is used as replacement therapy in adults who do not produce enough growth hormone (growth hormone deficiency). It is also used to treat children and adolescents who are not growing at the normal rate as a result of growth hormone deficiency and is given to patients from 3 years of age.
Growth hormone deficiency is rare, and Sogroya was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 24 August 2018. Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu3182068.
Sogroya contains the active substance somapacitan.
Sogroya is injected once a week using a pre-filled pen. It is injected under the skin in the belly, thighs, buttocks or upper arms and the injection site should be changed from one week to another. Patients or their caregivers can inject the dose themselves after appropriate training.
The medicine can only be obtained with a prescription and treatment should be started and monitored by doctors who are qualified and experienced in the diagnosis and management of patients with growth hormone deficiency (such as endocrinologists).
For more information about using Sogroya, see the package leaflet or contact your doctor or pharmacist.
The active substance in Sogroya, somapacitan, acts in the same way as human growth hormone. Once injected into the patient, it attaches to a protein in the blood called albumin, which makes it remain in the body for longer. This allows the medicine to be given once a week, compared with other growth hormone replacement therapies which are given daily.
One main study involving 300 adults with growth hormone deficiency showed that Sogroya was more effective than placebo (a dummy treatment) at lowering the amount of truncal body fat (fat around the stomach and abdomen) after 34 weeks of treatment. The study also showed that weekly treatment with Sogroya had a comparable effect on truncal body fat to daily injections of somatropin (another medicine for growth hormone deficiency).
Sogroya has also been studied in 200 children and adolescents (before puberty) with growth hormone deficiency who had not received growth hormone treatment before. The study showed that children who received weekly treatment with Sogroya grew at a comparable speed as children who were treated daily with somatropin.
For the full list of side effects of Sogroya, see the package leaflet.
The most common side effect with Sogroya (which may affect more than 1 in 10 people) is headache. Other common side effects (which may affect up to 1 in 10 people) include hypothyroidism (an underactive thyroid gland), reactions at injection site, peripheral oedema (swelling, especially of the ankles and feet), joint pain, hyperglycaemia (high blood glucose levels), tiredness and adrenocortical insufficiency (when the adrenal glands do not produce enough steroid hormones, primarily cortisol). In children and adolescents, another common side effect is pain in the arms and legs.
Sogroya must not be used if the patient has an active tumour. In patients with brain tumours, tumours must be inactive and cancer therapy must have been completed before starting Sogroya. Treatment should be stopped if the tumour grows. Sogroya must also not be used in patients with acute serious illness suffering from complications after open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions. Sogroya must not be used to promote growth in children whose bones have finished growing. For the full list of restrictions, see the package leaflet.
Sogroya was shown to be effective at lowering truncal fat percentage and improving other body composition parameters, such as lean body mass, in adults compared with placebo. Sogroya was also shown to promote growth in children and adolescents. Its effects are considered clinically relevant and comparable with those of daily somatropin injection.
The short-term safety profile of Sogroya appears similar to that of other growth hormone-containing medicines, and additional data on the long-term safety and benefits of the medicine will be provided from future studies.
The European Medicines Agency decided that Sogroya’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Sogroya have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Sogroya are continuously monitored. Side effects reported with Sogroya are carefully evaluated and any necessary action taken to protect patients.
Sogroya received a marketing authorisation valid throughout the EU on 31 March 2021.
Product information
Latest procedure affecting product information:
X/0006/G
24/07/2023
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Sogroya
- Active substance
- Somapacitan
- International non-proprietary name (INN) or common name
- somapacitan
- Therapeutic area (MeSH)
- Growth
- Anatomical therapeutic chemical (ATC) code
- H01AC07
Pharmacotherapeutic group
Pituitary and hypothalamic hormones and analoguesTherapeutic indication
Sogroya is indicated for the replacement of endogenous growth hormone (GH) in children aged 3 years and above, and adolescents with growth failure due to growth hormone deficiency (paediatric GHD), and in adults with growth hormone deficiency (adult GHD).
News on Sogroya
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