Serono Laboratories Inc.'s growth hormone releasing hormone(GHRH), Geref, moved closer to FDA approval recently when anFDA advisory panel voted five-to-two to recommend approval of thedrug for the treatment of children with human growth hormonedeficiency (GHD). The FDA generally follows the recommendationsof its advisory committees, although it is not bound to do so.
GHD is a condition whereby some children do not grow or developnormally due to inadequate levels of growth hormone. Unlikerecombinant human growth hormone products _ such as South SanFrancisco-based Genentech Inc.'s Protropin _ that replenish thehormone, GHRH stimulates the pituitary gland to produce moregrowth hormone on its own. Studies have shown that the majority ofchildren suffering from GHD are also GHRH-deficient.
Serono Labs, the U.S. unit of the Geneva, Switzerland-based Ares-Serono Group, filed a new drug application for Geref in 1993. OnFriday, the Norwell, Mass.-based company released a statementsaying "We are hopeful that the FDA will authorize the use of thisalternative therapy in selected patients, providing an additionaltherapeutic option to patients and their physicians." Geref is alreadyapproved for in vivo diagnostic use.
Other companies are also working on similar products. LastNovember, ICN Pharmaceuticals Inc., of Costa Mesa, Calif.,acquired the rights to develop and commercialize a group ofcompounds related to and including growth hormone releasing factor(GHRF) for the U.S. and other markets from Fujisawa USA Inc., ofJapan. Cambridge Biotech Corp., of Worcester, Mass., andBioNebraska, of Lincoln, Mass., are jointly developing arecombinant GHRF to prevent spontaneous fractures due toosteoporosis. _ Lisa Piercey
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