Important note: Information in this article was accurate in October 2003. The state of the art may have changed since the publication date.
 |
HIV Treatment Bulletin - October 2003
Simon Collins, HIV i-Base
On 29 August 2003 the US Food and Drug Administration (FDA) granted full approval for Serostim (somatropin; recombinant growth hormone for injection), which is indicated for the treatment of HIV patients with wasting or cachexia to increase lean body mass and body weight, and improve physical endurance.
FDA granted Serostim accelerated approval in 1996, a special regulatory status granted by the FDA for approval of a drug that is used to treat patients with serious or life-threatening illnesses, and provides meaningful therapeutic benefit over any existing treatments.
Under the terms of the accelerated approval, Serono conducted a multi-centre, confirmatory placebo-controlled study with Serostim. Data from this trial substantiate previous study findings of increased lean body mass and improvement in physical strength. In addition, patients in this study perceived an improvement in their wasting symptoms and in quality of life.Since 1996, rHGH has been widely prescribed in the US, although this has been through insurance-based healthcare and against the background of concerns for the high cost.
Within a week of the US decision the EMEA in Europe confirmed that it will not grant approval for the same drug for the same indication.
In April 2003, the European Medicines Evaluation Agency rejected Serono’s application to market Serostim for AIDS-related wasting syndrome. Serono formally appealed this decision in July, and following an expert meeting on 2 September the EMEA announced that the original April decision would be upheld and marketing authorisation would not be recommended.
Source: Serono press release
FDA full label
http://www.fda.gov/cder/foi/label/2003/20604se7-027_serostim_lbl.pdf
EMEA summary of opinion to appeal – 3 September 2003
Comment
The FDA approval was a consequence of the presentation of additional data from a recent trial by Serono as requested in 1996 when they granted conditional approval.
In contrast, in Europe Serono had no approval for the use for Serostim in wasting. The data from the recent multicenter trial showed a clear anabolic effect of Serostim in the study population as assessed by bicycle exercise.
However two major concerns were expressed by the EMEA with regard to this trial: first most patients included did not seem to fulfill the criteria of HIV-wasting, and second, the translation of bicycle workout into clinical benefit was difficult to accomplish. Other concerns raised were a negative impact of Serostim on lipoatrophy.
In addition the issue of a relapse of wasting after discontinuation of Serostim remained unresolved by the present data. The current transatlantic split will keep Serostim on the market, but will make it available for European patients with wasting only under exceptional circumstances, if at all.
031010
IB30408-21
©2003. I-BASE HIV Treatment Bulletin. Permission to reproduce courtesy of HIV i-Base, Third Floor East, Thrale House, 44-46 Southwark Street, London SE1 1UN - T: +44 (0) 20 7407 8488 F: +44 (0) 20 7407 8489
AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted grants from Boehringer Ingelheim, Elton John AIDS Foundation, iMetrikus, Inc., John M. Lloyd Foundation, the National Library of Medicine, and donations from users like you. Always watch for outdated information. This article first appeared in 2003. This material is designed to support, not replace, the relationship that exists between you and your doctor.
AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.
Copyright ©1980, 2003. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.
