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Weekly Drug News Round-Up: November 23, 2016

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

Xultophy 100/3.6 is expected to be available to patients in the first half of 2017 Read More...

This week the FDA approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec (Tresiba), and the 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. Xultophy 100/3.6 comes in a prefilled pen and is expected to be available to patients in the first half of 2017. Common side effects in trials included headache, nausea, diarrhea, increased lipase, and upper respiratory tract infection.

Sanofi’s Soliqua 100/33 Clears FDA for Type 2 Diabetes

Rates of low blood sugar were similar between Soliqua and Lantus-treated patients Read More...

The U.S. Food and Drug Administration 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, diarrhea, and nasopharyngitis. Soliqua 100/33 will be available in U.S. retail pharmacies 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 Read More...

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

FDA Expands Use of FluLaval Quadrivalent Vaccine to Infants

The CDC recommends that everyone aged 6 months and older get a seasonal flu vaccine each year Read More...

The FDA has expanded the patient population for GSK’s FluLaval Quadrivalent (influenza vaccine) to include infants 6 months and older. Prior to this, the quadrivalent (four-strain) vaccine was only approved for persons 3 years of age and older. With this approval, providers are now able to use the same dose of FluLaval Quadrivalent (15 mcg of hemagglutinin per virus strain in 0.5 mL) to vaccinate eligible recipients aged 6 months and older. Flu can be especially dangerous in children, with over 20,000 children under 5 years of age hospitalized each year due to flu.

Janssen's Darzalex Gains Enhanced Multiple Myeloma Approval

Originally approved in November 2015, Darzalex is an injectable human anti-CD38 monoclonal antibody Read More...

Multiple myeloma is an incurable blood cancer that occurs when cancerous plasma cells grow uncontrollably in the bone marrow. In response, the FDA has approved Janssen Biotech’s Darzalex (daratumumab), to be used in combination with dexamethasone and either Velcade (bortezomib) or Revlimid (lenalidomide) for patients who have received at least one prior therapy for this disease. Darzalex treatment with either of these added therapies significantly reduced the risk of disease progression or death by over 60% compared to the standard treatments used alone. In studies, common side effects included infusion reactions, diarrhea, and upper respiratory tract infections. Previously, Darzalex was approved to be used only after three other regimens had failed.