Needle-free hGH approved for HIV in USA

Serono and partner Bioject have been granted market clearance from theUS Food and Drug Administration for SeroJet, which delivers Serono's human growth hormone product Serostim (somatropin) for the treatment of AIDS wasting or cachexia using Bioject's needle-free device. SeroJet has demonstrated bioequivalence to needle injections in trials, but eliminates or reduces the risks associated with them, such as needle-stick injury and patient anxiety. Launch of the device is expected in the second half of 2001. This partnership also gained FDA market clearance in June 2000 for cool.click, a needle-free device which delivers Saizen (somatropin) for the treatment of growth hormone deficiency in children (Marketletter July 3, 2000).