Monthly News Roundup - July 2016
Injectable Adlyxin FDA-Approved for Type 2 Diabetes
The FDA has approved Sanofi’s Adlyxin (lixisenatide), a new once-daily injectable type 2 diabetes medication. Adlyxin is classified as an incretin mimetic/GLP-1 receptor agonist. For maintenance dosing, Adlyxin will be available in a disposable pre-filled pen of 20 micrograms. Adlyxin is given at mealtime and used alongside diet and exercise to improve blood sugar levels. In clinical studies, Adlyxin met the primary endpoint of hemoglobin A1c reduction, and the most common side effects included nausea, hypoglycemia (low blood sugar) and vomiting. Other drugs in the same class include liraglutide (Victoza), exenatide (Byetta, Bydureon) and dulaglutide (Trulicity).
AbbVie’s Once-Daily Viekira XR Approved for Genotype 1 HCV
Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir), a once-daily, extended-release tablet to treat chronic hepatitis C virus (HCV) genotype 1 infection, has been FDA-approved. Viekira XR is a fixed dose combination that contains the same ingredients as Viekira Pak, but in one single tablet. Viekira Pak is co-packaged with dasabuvir instead of having it all in one tablet. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. The XR tablet is used in combination with twice daily ribavirin in genotype 1a patients and without ribavirin in genotype 1b patients.
FDA Approves Longer Acting Belviq XR Tablets
Lorcaserin is a serotonin 2C receptor agonist indicated for chronic weight management in adults who are obese or overweight based on body mass index (BMI) with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol. This week, the FDA approved Eisai Inc. and Arena Pharmaceuticals’ Belviq XR (lorcaserin HCl) CIV extended-release 20 mg tablets taken once-daily. Belviq is the original 10 mg twice-daily formulation. Belviq XR is expected to be available commercially in the fall of 2016. Other more recent approvals for weight loss include Qsymia (phentermine and topiramate), Contrave (bupropion and naltrexone), and Saxenda (liraglutide).
Shire’s Xiidra Eyedrops Clear FDA for Dry Eye Disease
Xiidra (lifitegrast) eyedrops have been approved by the FDA to treat symptoms of dry eye disease in adults, a group of conditions related to insufficient tear production. Left untreated, dry eye can lead to pain, sores or scars on part of the eye called the cornea. Xiidra is the first approved medication among a new class of dry-eye drugs called lymphocyte function-associated antigen agonists. Clinical studies found those treated with Xiidra saw improvement in symptoms of dry eye, compared to placebo. The most common side effects of Xiidra include eye irritation, discomfort or blurred vision and an unusual taste sensation (dysgeusia)
Syndros, A Synthetic Marijuana Derivative, Wins FDA ApprovalThe FDA has cleared Syndros (dronabinol), an oral solution of the cannabinoid dronabinol and a synthetic version of THC found in marijuana. Syndros is approved for use in treating anorexia associated with weight loss in patients with AIDS, and nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments. The liquid formulation will allow easier titration and does not need to be refrigerated for 28 days once opened. Syndros is currently awaiting controlled substance scheduling by the DEA and it should be commercially available in the second half of 2016.
Posted: July 2016
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