(2003; 14 pages)
SOMATROPIN - Not to be authorized for AIDS-related wasting syndrome
Europe. The European Committee for Proprietary Medicinal Products (CPMP) has ruled out granting a marketing authorization for Serono’s orphan drug somatropin (Serostim), a recombinant growth hormone for AIDS-related wasting syndrome. Doubts about the clinical relevance of the primary endpoints used in the study, the lack of long-term efficacy data under controlled conditions and concerns about the long-term safety profile are being stated as reasons for this decision. The CPMP believes that the quality, safety and efficacy data suggest an unfavourable benefit to risk balance for somatropin (Serostim).
CPMP Summary of Opinion (CPMP/5330/02), 25 Apr 2003. Available from URL: http://www.emea.eu.int