Prospects of a European launch for Novartis’ irritable bowel syndrome drug Zelnorm all but vanished late last week, after the EU’s Committee for Medicinal Products for Human Use (CHMP) rejected the application for a second time.

The CHMP said it was not convinced that the benefits seen in clinical trials of would translate into real world settings, and that ‘its benefits were not greater than its risks’. The CHMP first rejected Zelnorm (tegaserod) in December 2005, for the same reasons, and looked at the dossier again after an appeal by Novartis.

The Swiss drugmaker said the decision to reject the serotonin-4 receptor agonist, which has been approved in 56 countries so far, including the USA, was ‘disappointing’, as Zelnorm has been shown to be an effective treatment for IBS, both in clinical trials and use by nearly 4 million patients since it was approved in 2002.

"We are disappointed with this decision that will prevent women in Europe to have access to Zelnorm,” said Dr James Shannon, head of global pharma development at Novartis Pharma.

Analysts said that the EU decision was disappointing for Novartis, but not a crushing blow as the lion’s share of the product’s sales potential lies in the USA. Zelnorm is already a useful earner for Novartis, racking up $418 million last year, up a healthy 40% year-on-year despite tighter warnings being added to its labelling in August 2004. These cited an increased risk of serious diarrhoea and a condition where blood flow to the intestines is impaired.

Indeed, Zelnorm has been tipped by some to reach $1 billion in US sales alone by 2010, with a further $300 million contributed from non-US markets.

Meanwhile, the CHMP also adopted positive opinions on:

  • Allergan’s Ganfort (bimatoprost/timolol), an eye-drop solution intended for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who do not respond to topical beta-blockers or prostaglandin analogues;
  • Adding prevention of post-operative nausea and vomiting to the approved indications for Merck Sharp & Dohme’s Emend (aprepitant), currently approved for prevention of nausea and vomiting in chemotherapy; and
  • Adding treatment of myoclonic seizures in patients with juvenile myoclonic epilepsy to the approved uses of UCB’s Keppra (levetiracetam), currently cleared for adjunctive therapy of partial onset seizures.