Merck Serono growth hormone gains European approval
Saizen Solution For Injection eliminates need to reconstitute powder for injection
Merck Serono has completed the Decentralised Procedure (DCP) allowing for approval of Saizen Solution For Injection (somatropin) in Europe.
The Switzerland-based division of Merck KGaA said marketing authorisations enabling sales of the drug in 18 European countries are expected over the next few months. The product will then be launched during 2011.
Saizen Solution For Injection is a liquid formulation of Merck Serono's recombinant growth hormone, which is indicated in Europe for the treatment of growth hormone deficiency in children and adults, as well as for growth promotion in children born small for gestational age, and in those with Turner Syndrome or chronic renal failure.
The new formulation will be available in 6mg, 12mg and 20mg cartridges, designed for exclusive use with Merck Serono's Easypod electronic injection device and Cool.click needle-free auto-injector.
‘Used with Easypod, the different cartridge options for Saizen Solution For Injection offer the flexibility to administer in a single injection a wide range of doses from 0.15–6.4mg, which is the highest dose available in Europe for a liquid formulation,’ said Fereydoun Firouz, head of Merck Serono’s Global Business Unit Fertility and Endocrinology.
Professor Pierre Chatelain, of Hôpital Mère-Enfant, Claude Bernard University, Lyon, France, added: ‘Adherence to treatment is one of the most important factors behind success of growth hormone treatment and I believe that simplifying the injection process can help patient be more adherent with their treatment regimen.’
It is estimated that the incidence of growth hormone deficiency in children is between 1 in 4,000 and 1 in 10,000.
Adult growth hormone deficiency affects 3 in 10,000 each year.
Saizen Solution For Injection is not available in the US.