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Monthly News Roundup - November 2016

Novo Nordisk’s Xultophy 100/3.6 FDA-Approved for Type 2 Diabetes

This month the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec (Tresiba), and the glucagon-like peptide-1 (GLP-1) agonist liraglutide (Victoza), used with diet and exercise to improve blood sugar control in type 2 diabetes. Xultophy is used in adults inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily. Common side effects include headache, nausea, and diarrhea. Xultophy 100/3.6 is expected to be available to patients in the first half of 2017.

Soliqua 100/33 from Sanofi Clears FDA for Type 2 Diabetes

The FDA has approved Sanofi’s once-daily Soliqua 100/33 injection, a combination of insulin glargine 100 Units/mL (Lantus) and lixisenatide 33 mcg/mL (Adlyxin), a glucagon-like peptide-1 (GLP-1) agonist. Soliqua 100/33 is indicated alongside diet and exercise to control blood sugar in adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 units daily) or lixisenatide. In studies, the most frequent side effects included low blood sugar, nausea, and diarrhea. Soliqua 100/33 will be available in January 2017 as a single dose, pre-filled pen.

Intrarosa Wins Approval to Treat Painful Sex in Menopause

During menopause, levels of estrogen decline in vaginal tissues leading to painful sex for some women. Intrarosa (prasterone) is a once-daily vaginal insert now cleared by the FDA to treat postmenopausal women experiencing moderate to severe pain during sexual intercourse (dyspareunia) as a symptom of vulvar and vaginal atrophy (VVA). In two 12-week placebo-controlled clinical studies in 406 postmenopausal women, Intrarosa was shown to reduce the severity of pain experienced during sexual intercourse when compared to placebo. The most common side effects include vaginal discharge and abnormal Pap smear.

FDA Gives Nod to Gilead’s Vemlidy for Chronic HBV Infection

Chronic hepatitis B is a life-threatening virus that affects up to 2.2 million people in the U.S. Vemlidy (tenofovir alafenamide, TAF) 25 mg was FDA approved as a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease (exhibiting no symptoms). Vemlidy is an HBV nucleoside analog reverse transcriptase inhibitor and a tenofovir prodrug with similar antiviral effectiveness. However, due to lower dosing resulting in less tenofovir in the bloodstream, Vemlidy has shown improved kidney and bone laboratory safety parameters compared to Viread (tenofovir disoproxil fumarate, TDF). Vemlidy labeling contains boxed warnings, one regarding lactic acidosis/severe hepatomegaly.

Opdivo Approval Based on Overall Survival in Head & Neck Cancer

More than half of squamous cell head and neck cancer patients are initially diagnosed with Stage III or higher disease. The FDA has now approved Bristol-Myers Squibb's Opdivo (nivolumab) injection to treat advanced squamous cell cancer of the head and neck that has progressed on or after a platinum-based therapy. In the Phase III CheckMate-141 trial, Opdivo extended overall survival (OS) in these patients. The median OS was 7.5 months for Opdivo compared to 5.1 months for methotrexate, docetaxel or cetuximab. Opdivo can be associated with immune-mediated side effects, including inflammations of the lung, colon, liver, and kidney.

Posted: November 2016


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