Zelnorm Rejected Again in Europe
04/02/06 03:25 PM
The European Medicines Agency's (EMEA) review committee has recommended against the approval of Swiss drug major Novartis' Zelnorm (tegaserod) for the treatment of women suffering from irritable bowel syndrome with constipation.
This advice followed an appeal procedure undertaken by the firm in December 2005 after the first time that the EMEA's Committee for Medicinal Products for Human Use recommended that the European Commission not approve the serotonin-4 receptor blocker.
Tegaserod, the active ingredient in Zelnorm, is a receptor agonist. It activates receptors in the body, known as 5-hydroxytryptamine (5HT) type 4 receptors. When these receptors are activated in the bowels, peristalsis that moves food along the bowels is stimulated. They also potentially reduce the sensitivity of the bowel. These effects are expected to relieve the symptoms described.
Which documentation has been presented by the Company to support the application to the CHMP?
The effects of Zelnorm were first tested in experimental models before being studied in humans. The main study in humans was done in 2660 women aged 18 to 65 years, and with symptoms of irritable bowel syndrome with constipation. The study compared Zelnorm 6 mg to placebo (a dummy treatment). Treatments were double blinded (neither the patients nor the doctors knew which treatment had been given until the end of the study).
The study looked at the effectiveness of Zelnorm to relieve the overall symptoms of the disease and discomfort or pain in the stomach or abdomen.
Which were the major concerns, which lead to the refusal of the marketing authorisation by the CHMP?
The CHMP was concerned that the results of the study would not translate into real benefit to the patient treated to relieve the symptoms of this disorder in standard health care setting. The CHMP was of the opinion that Zelnorm’s benefits are not greater than its risks. Hence, the CHMP recommended that Zelnorm be refused marketing authorisation.
Commenting on the CHMP's decision, James Shannon, head of global drug development at Novartis Pharma, said he was disappointed.