Biopartners GmbH, a wholly owned subsidiary of Bioton SA, Poland, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion regarding the approval of once-weekly Somatropin Biopartners for the treatment of growth hormone deficiency (GHD) in paediatric and adult patients. The CHMP’s recommendation is now referred to the European Commission (EC) which grants approval for the European Union, Norway and Iceland. The EC decision is anticipated in the middle of the third quarter of 2013.
Somatropin Biopartners is the first prolonged-release somatropin-containing medicinal product to receive a positive CHMP opinion. Somatropin Biopartners will allow for a once-weekly subcutaneous injection instead of the currently available therapies that require once-daily injections of growth hormone (GH). Poor adherence and noncompliance have been identified as a major cause of suboptimal efficacy of current GH replacement therapy in children as well as adults.
The typical symptom of GHD in children is growth failure, and consequently the aim of treatment is the normalisation of the growth rate during childhood and attainment of normal adult height.
The clinical features associated with GHD in adults include abdominal obesity, decreased lean body mass, reduced muscle strength and exercise capacity, abnormalities in lipid and cardiovascular markers, decreased bone mineral density and impaired quality of life.
In Phase III comparative trials in children and adults, respectively, which were conducted as part of a joint development programme with LG Life Sciences Ltd., Somatropin Biopartners proved to be safe and effective, showing sustained growth in children and beneficial effects on body composition in adults.