Overview

This is a summary of the European public assessment report (EPAR) for Increlex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Increlex.

Increlex is a solution for injection that contains the active substance mecasermin.

Increlex is used for the long-term treatment of patients aged two to 18 years who are short for their age due to a condition known as ‘severe primary insulin-like-growth-factor-1 deficiency’. Patients with this condition have low levels of the hormone insulin-like growth factor-1 or IGF-1, which is required for normal growth.

Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘rare’, and Increlex was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 22 May 2006.

The medicine can only be obtained with a prescription.

Treatment with Increlex should be supervised by doctors who have experience in the diagnosis and treatment of patients with growth disorders.

The recommended starting dose is 0.04 mg per kilogram body weight twice a day. The dose should be tailored for each patient according to the speed of growth and side effects. The maximum dose is 0.12 mg per kilogram twice a day. Increlex is given by injection under the skin, and the injection site should be changed with each injection. It should never be injected into a vein. The injection should be carried out shortly before or after a meal or snack. Treatment should be interrupted if the patient cannot eat for any reason. For more information, see the summary of product characteristics.

The active substance in Increlex, mecasermin, is a copy of the hormone IGF-1. IGF-1 is important in determining how tall a child grows. It does this by stimulating cells to divide and grow and to absorb nutrients, supporting the growth of body tissues. Increlex works in the same way as natural IGF-1, replacing the missing hormone and helping the child to grow taller.

Increlex has been studied in five studies involving a total of 76 children aged between one and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies. Because the disease is rare, many of the children were included in more than one of the studies. One study compared Increlex with placebo (a dummy treatment) in eight patients, but the others did not compare Increlex with any other treatments. The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.

Increlex caused the speed of growth to increase. When the results of the studies were looked at together, the average growth rate was 2.8 cm per year before treatment. This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second. The growth rate stabilised at around 4.7 cm per year from the fourth year of treatment.

Some of the studies also included children who had defects in the gene for growth hormone (GH) and who had developed antibodies against GH. The company applied for an authorisation to use Increlex in these children, but withdrew its application after the end of the medicine’s assessment, as this disease is not listed in the medicine’s ‘orphan’ designation.

The most common side effects with Increlex (seen in more than 1 patient in 10) are headache, hypoglycaemia (low blood sugar levels), vomiting (being sick), injection site hypertrophy (lumps at the site of injection) and otitis media (infection of the middle ear).

Increlex must not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth). Treatment with Increlex should be stopped if neoplasia develops. Increlex must not be used in premature babies or newborns. For the full list of all side effects and restrictions with Increlex, see the package leaflet.

The CHMP decided that Increlex’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Increlex has been authorised under ‘exceptional circumstances’. This means that because the disease is rare, it has not been possible to obtain complete information about Increlex. Every year, the European Medicines Agency will review any new information that may become available and this summary will be updated as necessary.

The company that makes Increlex will carry out a long-term study looking at the safety of the medicine, when treatment is started in young children and continued into adulthood.

A risk management plan has been developed to ensure that Increlex is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Increlex, including the appropriate precautions to be followed by healthcare professionals and patients.

Additionally, the company that markets Increlex will supply information packs to doctors and patients explaining how the medicine is used and its side effects. The company will also supply dose calculators to help doctors and patients (or their carers) to work out the appropriate dose.

The European Commission granted a marketing authorisation valid throughout the European Union for Increlex on 3 August 2007.

For more information about treatment with Increlex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Increlex : EPAR - Summary for the public

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Increlex : EPAR - Risk-management-plan summary

Product information

Increlex : EPAR - Product Information

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Latest procedure affecting product information: II/0080

26/10/2023

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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).

Increlex : EPAR - All Authorised presentations

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Product details

Name of medicine
Increlex
Active substance
Mecasermin
International non-proprietary name (INN) or common name
mecasermin
Therapeutic area (MeSH)
Laron Syndrome
Anatomical therapeutic chemical (ATC) code
H01AC03

Pharmacotherapeutic group

Pituitary and hypothalamic hormones and analogues

Therapeutic indication

For the long-term treatment of growth failure in children and adolescents with severe primary insulin-like-growth-factor-1 deficiency (primary IGFD).

Severe primary IGFD is defined by:

  • height standard deviation score ? -3.0 and;
  • basal insulin-like growth factor-1 (IGF-1) levels below the 2.5th percentile for age and gender and;
  • growth hormone (GH) sufficiency;
  • exclusion of secondary forms of IGF-1 deficiency, such as malnutrition, hypothyroidism, or chronic treatment with pharmacologic doses of anti-inflammatory steroids.

Severe primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signalling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment. It is recommended to confirm the diagnosis by conducting an IGF-1 generation test.

Authorisation details

EMA product number
EMEA/H/C/000704

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Exceptional circumstances

This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

Marketing authorisation holder
Ipsen Pharma

65 Quai Georges Gorse
92100 Boulogne-Billancourt
France

Marketing authorisation issued
02/08/2007
Revision
25

Assessment history

Increlex : EPAR - Procedural steps taken and scientific information after authorisation

Increlex-H-C-704-P46-054.1 : EPAR - Assessment Report

Increlex-H-C-PSUSA-00001942-201408 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

Increlex-H-C-704-P46-050.2 : EPAR - Assessment Report

Increlex : EPAR - Scientific Discussion

Increlex : EPAR - Procedural steps taken before authorisation

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