CPMP OKs Pharmacia's Igef And Genotropin

The European Union's Committee on Proprietary Medicinal Products has recommended the approval of two of Pharmacia's products. The Swedish company's best-selling Genotropin (human growth hormone) product receives a positive opinion for the treatment of an additional indication, treating adults with growth hormone deficiency, while its Igef (insulin-like growth factor 1) should be approved for the treatment of children with growth disorders resulting from an insensitivity to growth hormone, according to the CPMP.

Member countries of the EU are expected to follow the recommendation and approve the drugs for the aforementioned indications.

Pharmacia believes the expanded indication for Genotropin is a real breakthrough for the company, which is already a world leader in the human growth hormone market with a 50% share outside the USA. It is the first hGH product to be approved for this indication. Extending the indications for Genotropin to include adult patients with hGH deficiency will raise the target population by tens of thousands of patients worldwide, and at current prices, the market is valued at more than 1 billion kroner ($135 million).