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Weekly Drug News Round-Up: December 6, 2017

Novo Nordisk Gains FDA Approval of Ozempic for Type 2 Diabetes

Ozempic is suitable for once-weekly dosing due to high albumin binding and a longer half-life Read More...

The US Food and Drug Administration (FDA) has approved Novo Nordisk’s Ozempic (semaglutide), a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the treatment of adults with type 2 diabetes. Ozempic is approved for use in two therapeutic doses, 0.5 mg and 1 mg, and will be launched in the Ozempic pre-filled pen. In Phase 3 studies, Ozempic showed significant reductions in A1c compared with placebo, sitagliptin (Januvia) and exenatide extended-release (Bydureon); a reduction in body weight was also seen. The most common adverse reactions reported in 5% or greater of patients treated with Ozempic included nausea, vomiting, diarrhea, abdominal pain and constipation.

FDA Approves Ogivri, the Second Biosimilar for Cancer

Ogivri has not been approved as an interchangeable product Read More...

This past week the FDA approved Mylan and Biocon's Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab), for the treatment of patients with HER2+ breast cancer or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. Ogivri is a HER2/neu receptor antagonist. Side effects can vary, but may include headache, fatigue, diarrhea, anemia, nausea, fever, infection, difficulty sleeping (insomnia), and worsening of neutropenia.

Sublocade is Indivior’s Once-Monthly Injection for Opioid Use Disorder

Sublocade may reduce the burden of taking daily medication for patients in recovery Read More...

Sublocade is the first once-monthly injectable buprenorphine product now FDA-approved for the treatment of moderate-to-severe opioid use disorder (OUD) in adults who have initiated treatment with a transmucosal (absorbed via mucus membrane) buprenorphine-containing product. Buprenorphine for OUD is also approved as a tablet or film that dissolves in the mouth, or as an implant. A partial opioid agonist formulation, Sublocade is used in patients already on a stable dose of buprenorphine for a minimum of 7 days. In studies, Sublocade-treated patients had more weeks without positive urine tests or self-reports of opioid use compared to the placebo group.

Clenpiq Cleared As Low Volume Bowel Prep Agent

The large volume of certain prescribed bowel prep solutions can be a barrier for some patients Read More…

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid), from Ferring Pharmaceuticals, is a low volume, pre-mixed, stimulant and osmotic laxative combination now approved for cleansing of the colon as a preparation for colonoscopy in adults. Clenpiq, which is cranberry-flavored, is the only FDA-approved prescription colonoscopy prep that comes “ready-to-drink”. Sodium picosulfate is a stimulant laxative, and magnesium oxide and anhydrous citric acid, which forms magnesium citrate, is an osmotic laxative. Commercial availability is expected in the first quarter of 2018.

FDA Alert: Biotin (Vitamin B7) May Interfere with Lab Tests

Biotin is found in multivitamins, prenatal vitamins, biotin supplements, and other OTC products for hair, skin, and nail growth Read More...

The FDA has released a safety alert that the over-the-counter (OTC) supplement biotin, also known as vitamin B7, may interfere with lab tests. Many lab tests use biotin technology to detect certain health conditions. For example, biotin is used in hormone tests and in tests for markers of heart health. Physicians may also recommend high levels of biotin for patients with certain conditions such as multiple sclerosis (MS). Biotin levels higher than the recommended daily allowance may cause interference with lab tests. Talk to your doctor if you are currently taking biotin or are considering adding biotin, or a supplement containing biotin, to your diet.