Merck Serono completes DCP for Saizen solution for injection approval

Merck Serono said that the marketing authorisations enabling commercial sales in the individual countries are expected over the next several months.

Saizen solution for injection is a liquid formulation of Merck Serono’s recombinant growth hormone Saizen indicated in Europe for the treatment of growth hormone deficiency in children and adult patients, as well as for growth promotion in Children Born Small for Gestational Age, and in children with Turner Syndrome or Chronic Renal Failure.

The new formulation is expected to be available in cartridges of 6mg, 12mg and 20mg, designed for exclusive use with Merck Serono’s electronic injection device easypod and needle-free auto-injector cool.

Merck Serono Global Business Unit Fertility and Endocrinology head Fereydoun Firouz said that since the launch of Saizen, Merck Serono has continuously developed new options to facilitate the delivery of Saizen therapy.

"Used in conjunction 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 0.15mg to 6.4mg, which is the highest dose available in Europe for a liquid formulation," Firouz said.

Merck Serono said that in Europe, the launch of Saizen solution for injection will be rolled out in the course of 2011 following the granting of the national marketing authorisations.