Serono's Saizen Approvable, Says FDA

Serono Laboratories, the US subsidiary of Ares-Serono, said last week that the US regulatory authorities had issued an approvable letter for its mammalian cell-derived recombinant human growth hormone product Saizen, for the treatment of children with growth hormone deficiency.

The agency has required some additional data prior to approving the drug, which the company says it will work quickly to supply. Saizen is already cleared in the USA for the treatment of Turner's syndrome, but growth hormone deficiency, which is estimated to affect one child out of every 5,000, is a much larger market. Saizen is currently marketed in over 60 non-US countries for this condition.