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Monthly News Roundup - February 2017

FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl peptidase-4 (DPP4) inhibitor treatment for adults with type 2 diabetes. This new combination agent is to be used alongside diet and exercise in those without adequate blood sugar control with dapagliflozin or who are already treated with dapagliflozin (Farxiga) and saxagliptin (Onglyza). FDA approved Qtern based on data from a trial looking at efficacy and safety of saxagliptin added to dapagliflozin in patients with inadequate control on metformin. cleared:

Xermelo: First Oral Agent for Carcinoid Syndrome Diarrhea in Cancer Patients

The FDA has given the green light to Lexicon’s Xermelo (telotristat ethyl), an oral tryptophan hydroxylase inhibitor used in combination with somatostatin analog (SSA) therapy for the treatment of carcinoid syndrome diarrhea in cancer patients with metastatic neuroendocrine tumors (mNET). mNETs are abnormal growths that start in neuroendocrine cells found throughout the body. Xermelo targets the overproduction of serotonin inside mNET cells to lessen carcinoid syndrome diarrhea. Constipation and/or worsening abdominal pain may be severe side effects. Common side effects include nausea, headache, depression, decreased appetite, and fever, among others.

Suicide Warnings Linked to FDA Approval of Siliq for Psoriasis

Plaque psoriasis is an autoimmune skin disorder that leads to unsightly, red, and flaky patches of skin. In February, the FDA approved Siliq (brodalumab) injection, an anti-interleukin-17-receptor monoclonal antibody from Valeant Pharmaceuticals, to treat adults with moderate-to-severe plaque psoriasis. In three randomized, placebo-controlled studies with 4,373 patients, more Siliq-treated patients had clear or almost clear skin compared to placebo-treated patients. Suicidal ideation and behavior, including completed suicides, occurred in patients treated with Siliq during trials, but a causal association has not been determined. Due to this possible risk, a restricted access program is in place.

Marathon’s Emflaza Approved for Duchenne Muscular Dystrophy

Duchenne muscular dystrophy (DMD) is a rare genetic disorder that causes progressive muscle deterioration and weakness. This month the FDA approved Emflaza (deflazacort), a glucocorticoid for the treatment of Duchenne Muscular Dystrophy in patients age 5 years of age and older. Emflaza effectiveness was shown in a clinical study of 196 male patients 5 to 15 years. At week 12, Emflaza patients had improvements in clinical assessment of muscle strength compared to placebo, which was maintained through week 52. Emflaza will be available in tablet and oral suspension form, but the date of commercial availability for the product is still unknown.

Parsabiv Cleared for Secondary Hyperparathyroidism in Chronic Kidney Disease

Amgen’s Parsabiv (etelcalcetide) is the first new therapy for secondary hyperparathyroidism (HPT) in chronic kidney disease (CKD) in patients on hemodialysis in over a decade. Parsabiv’s mechanism of action is activation of the calcium-sensing receptor on the parathyroid gland to lower PTH levels. Approval was based on 2, 26-week Phase 3 studies with 1,023 patients with moderate-to-severe secondary HPT (PTH greater than 400 pg/mL) on hemodialysis. Significantly more Parsabiv patients met the primary endpoint of a greater than 30% reduction from baseline in PTH compared to placebo: 77 percent versus 11 percent in Study 1, and 79 percent versus 11 percent in Study 2, respectively.

Posted: February 2017