FDA gives word that Lexicon has been given approval for telotristat

The price could hit $72,000 at the top of the range per patient per year, according to analysts

Lexicon Pharmaceuticals saw its shares bounce 8% premarket this morning on news out late last night that the FDA had approved its oral med Xermelo (telotristat ethyl) for patients with certain GI tumors suffering from the rare condition known as carcinoid syndrome diarrhea.

Lexicon says its new offering is the first and only oral drug combo (it’s used with somatostatin analog, or SSA, therapy) in those whose condition is not controlled on SSA therapy alone. These older drugs include Novartis’ Sandostatin LAR depot and Ipsen’s Somatuline.

The company in fact has a marketing deal with France’s Ipsen in Europe for the new treatment.

The drug, which was delayed by several months by the FDA so it could spend more time on a review, is deisgned to zero-in on tryptophan hydroxylase, an enzyme that facilitates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells.

The price could hit $72,000 at the top of the range per patient per year, according to analysts.

Lonnel Coats, Lexicon’s president and CEO, said the approval: “Represents a shift in the treatment paradigm of carcinoid syndrome diarrhea for cancer patients who are inadequately controlled by SSA therapy, and until now, have had limited options to manage this debilitating condition.

 “We are proud to have discovered and developed this ground-breaking orphan drug, and it is an honor to make it available for the thousands of patients currently suffering from this condition who wish to lead a more routine life with fewer incidences of severe diarrhea.”

This comes after a positive end to 2016 when Lexicon and its partner Sanofi announced positive results for the late-stage study of its Big Pharma-backed diabetes candidate sotagliflozin.