Serono slams CPMP decision on Serostim.

Pharma Marketletter, May, 2003

Switzerland's Serono has taken issue with the decision by the European Union's Committee on Proprietary Medicinal Products not to recommend granting marketing authorization for Serostim (somatropin), the firm's growth hormone-based treatment for AIDS wasting.

The CPMP issued a negative opinion on Serostim, which has orphan status in the EU, on the grounds that it could not identify a target population suitable for treatment with the drug. The panel said that Serono's study in support of the marketing application (GF9037) had too much heterogeneity in terms of the patients' body composition and antiretroviral treatment options.

It also took issue with the clinical endpoint used in the trial, saying that "the clinical relevance of the positive effect of...