Product Approval Summaries

DRUGS

FDA has approved a Serenity Pharmaceuticals NDA for Noctiva (desmopressin acetate) nasal spray for adults who awaken at least two times per night to urinate due to a condition known as nocturnal polyuria (overproduction of urine during the night). Approval was based on data from two 12-week trials in 1,045 patients 50 years of age and older with nocturia. “Although these trials showed a small reduction in the average number of night-time urinations with Noctiva compared to placebo, more patients treated with Noctiva were able to at least halve their number of night-time urinations, and patients treated with Noctiva had more nights with one or fewer night-time urinations,” an FDA release says.

FDA has approved Merck, Sharp & Dohme’s Odactra, the first allergen extract to be administered under the tongue (sublingually) to treat house dust mite-induced nasal inflammation with or without eye inflammation in people aged 18 to 65 years. “Odactra exposes patients to house dust mite allergens, gradually training the immune system in order to reduce the frequency and severity of nasal and eye allergy symptoms,” an FDA release says. Approval was based on studies conducted in the U.S., Canada and Europe, involving about 2,500 people. “During treatment, participants taking Odactra experienced a 16% to 18% reduction in symptoms and the need for additional medications compared to those who received a placebo,” the agency says.

FDA has approved a Lexicon Pharmaceuticals NDA for Xermelo (telotristat ethyl) tablets in combination with somatostatin analog (SSA) therapy for treating adults with carcinoid syndrome diarrhea that SSA therapy alone has inadequately controlled. Carcinoid syndrome occurs in less than 10% of patients with carcinoid tumors, usually after the tumor has spread to the liver, according to an FDA release. “The tumors in these patients release excess amounts of the hormone serotonin, resulting in diarrhea,” it says.

FDA has approved an AstraZeneca NDA for once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for treating type-2 diabetes. The combination drug is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin. “The approval of Qtern is good news for patients who may benefit from improved glycemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet,” the company says. “SGLT-2 inhibitors help patients achieve improved glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors, including Farxiga (dapagliflozin), have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c.

DEVICES

FDA has approved a CeloNova BioSciences PMA for its first-in-class Cobra PzF NanoCoated Coronary Stent System, indicated for improving coronary luminal diameter in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries with reference vessel diameter of 2.5-4.0mm and lesion length less-than 24mm. The company says the device is coated with a proprietary nano-thin polymer that is designed to be highly biocompatible, and it requires a minimum 30-day dual antiplatelet therapy regimen following intervention. Approval was based on findings from the pivotal PzF SHIELD clinical trial that demonstrated no stent thrombosis and low clinically driven target lesion revascularization of 4.6%, the company says.