Lexicon's Xermelo garners FDA approval for treatment of carcinoid syndrome diarrhoea

The FDA approved Lexicon Pharmaceuticals' Xermelo (telotristat ethyl) in combination with somatostatin analogue (SSA) therapy for the treatment of adults with carcinoid syndrome diarrhoea that SSA therapy alone has inadequately controlled. The agency noted that the oral tryptophan hydroxylase inhibitor hampers the production of serotonin by carcinoid tumours and reduces the frequency of carcinoid syndrome diarrhoea.

According to the FDA, approval of Xermelo was backed by safety and efficacy data from a study of 90 adults with well-differentiated metastatic neuroendocrine tumours and carcinoid syndrome diarrhoea that was not controlled by SSA therapy alone. Results demonstrated that the addition of Xermelo to SSA therapy produced reductions in daily bowel movements versus placebo. Specifically, 33 percent of participants given Xermelo experienced an average reduction of two bowel movements per day compared to 4 percent of patients who received placebo.

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Lexicon CEO Lonnel Coats stated "today's approval of Xermelo represents a shift in the treatment paradigm of carcinoid syndrome diarrhoea for cancer patients who are inadequately controlled by SSA therapy, and until now, have had limited options to manage this debilitating condition." The drugmaker noted that the therapy will be launched on March 6 at a price of $5164 for a 28-day supply.

Xermelo was previously awarded priority review and orphan drug designation designation by the FDA for the treatment of carcinoid syndrome diarrhoea, in addition to fast track status. The agency extended its review of the drug by three months in September 2016 to review additional clinical data analyses submitted following an information request by the regulator.

Lexicon retains commercialisation rights to Xermelo in the US and Japan, while the company has established a licence and collaboration agreement with Ipsen to market the drug in Europe and other countries outside of these territories.