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Weekly Drug News Round-Up: March 1, 2017

FDA Approves Once-Daily Qtern Tablets for Type 2 Diabetes

Type 2 diabetes affects more than 29 million people in the US alone Read More...

This week the U.S. Food and Drug Administration (FDA) 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.

Xermelo Wins Approval for Carcinoid Syndrome Diarrhea in Cancer Patients

Xermelo is an orphan drug and will be in select specialty pharmacies beginning March 6, 2017 Read More...

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.

Celgene's Revlimid Receives Expanded Indication in Multiple Myeloma

Revlimid is the first drug approved for maintenance use following autologous hematopoietic stem cell transplant Read More...

The U.S. Food and Drug Administration (FDA) has expanded the approved indications for Revlimid (lenalidomide) to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant (auto-HSCT). Approval was based on 2 studies with over 1,000 patients who received Revlimid maintenance therapy until disease progression or unacceptable toxicity after auto-HSCT or no maintenance. The primary endpoint was progression-free survival (PFS). In the most recent U.S. evaluation, patients demonstrated a median PFS of 5.7 years versus 1.9 years for no maintenance, a difference of 3.8 years.

Flu Antivirals Safe in Mid-to-Late Pregnancy: Study

All pregnant women in any trimester are advised to get the flu shot, per the CDC Read More...

When influenza hits during a pregnancy, it can be dangerous to both mother and baby. So how safe are antiviral flu treatments like oseltamivir (Tamiflu) or zanamivir (Relenza) for pregnant women? Researchers reviewed data from 6,000 pregnant women who received antivirals for the flu after the 22nd week of pregnancy. When compared to nearly 700,000 expectant mothers who didn't take the drugs during pregnancy, the experts found babies born to mothers prescribed the antiviral drugs didn't have higher rates of complications, including low birth weight, preterm birth, stillbirth and birth defects.

Serious Bleeding Risks from Common Blood Thinners: Study

Patients who need blood thinners should not stop them, but should discuss possible side effects with their provider Read More...

Blood thinners like warfarin, low-dose aspirin or clopidogrel (Plavix) are life-saving drugs used by millions to prevent clots. But what are their serious bleeding risks? As published in the February 28 issue of the Journal of the American Medical Association (JAMA), researchers found that use of certain blood thinners can boost the odds of a subdural hematoma, a serious bleed near the brain. The risk was particularly high for patients combining blood thinners, like warfarin with low-dose aspirin or clopidogrel (Plavix). Individually, low-dose aspirin was linked with a small risk of subdural bleed. Newer agents like Pradaxa, Xarelto, and Eliquis are other options with a lower risk of intracranial bleeding.