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Weekly Drug News Round-Up: April 6, 2016

Second U.S. Biosimilar Inflectra is FDA-Approved

A biosimilar must have no clinically meaningful safety or effectiveness differences from the reference product Read More...

The biosimilar market is starting to heat up. Yesterday, the US Food and Drug Administration (FDA) cleared the second U.S. biosimilar, Inflectra (infliximab-dyyb) by Celltrion. Inflectra, a tumor necrosis factor (TNF) blocker, is biosimilar to Janssen’s Remicade (infliximab) originally approved in 1998. Inflectra can be prescribed for the same indications as Remicade, including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis (spine arthritis), ulcerative colitis, psoriatic arthritis, and plaque psoriasis. The first US biosimilar, Zarxio (filgrastim-sndz) from Sandoz, was approved in March 2015.

Descovy: FDA Approves Gilead’s Third TAF-Based HIV Therapy

TAF is tenofovir alafenamide, a prodrug of tenofovir given at a dose less than one-tenth that of tenofovir disoproxil fumarate Read More...

The FDA has approved Descovy (emtricitabine and tenofovir alafenamide [TAF]), Gilead’s nucleoside analog HIV-1 reverse transcriptase inhibitor (NRTI) and nucleotide reverse transcriptase inhibitor (NtRTI) fixed-dose combination for the treatment of HIV-1 infection. TAF provides lower levels of drug in the blood, but higher levels within the cells where HIV-1 replicates. TAF was developed to help reduce some drug side effects linked with regular tenofovir like kidney toxicity and decreases in bone density. Descovy is used with other antiretroviral agents to treat HIV-1 in adults and children 12 years and older. Genvoya and Odefsey are other HIV-1 treatments from Gilead approved in the last 6 months that also contain TAF.

FDA Alert: Certain Diabetes Drugs May Elevate Heart Failure Risk

Providers should consider stopping these medications in patients who develop heart failure Read More...

Saxagliptin and alogliptin are dipeptidyl peptidase-4 (DPP-4) inhibitors used to lower blood sugar in adults with type 2 diabetes. On Tuesday, FDA issued a warning that these drugs may increase heart failure risk, especially in patients who already have kidney or heart disease. Medicines that contain saxagliptin and alogliptin include Onglyza (saxagliptin), Kombiglyze XR (saxagliptin and metformin ER), Nesina (alogliptin), Kazano (alogliptin and metformin), and Oseni (alogliptin and pioglitazone). Patients who take these drugs should contact their doctor if they notice signs of heart failure (shortness of breath, trouble breathing, tiredness or weakness, weight gain, swelling). Patients should not stop their medication unless directed to do so by their doctor.

Study Reaffirms No Link Between Certain Birth Defects and Seizure Drug

Lamotrigine may be used to control seizures or for bipolar disorder Read More…

A new, large multinational study has shown that the use of lamotrigine (Lamictal) by women during pregnancy may not raise the risk for certain birth defects such as cleft palate or cleft lip. Researchers analyzed data on more than 10 million births over 16 years, which included almost 227,000 babies with birth defects; 147 of these babies had mothers who used lamotrigine during the first trimester of pregnancy. However, babies born with cleft lip, cleft palate or clubfoot were not significantly more likely than those with other birth defects to have been born to mothers who took lamotrigine in the first trimester of pregnancy, the study found.

Got Insulin? Prices Skyrocket Over the Last Decade

People with diabetes use insulin shots to help them break down glucose as fuel for the body Read More...

Prices of insulin in the US have more than tripled in the last 10 years, according to a new study in Journal of the American Medical Association. A switch in the marketplace to analog insulins, such as Lantus (insulin glargine) and Levemir (insulin detemir), may be one reason; insulin analogs are now replacing human insulin in the US. The study authors found that between 2002 and 2013 insulin costs per milliliter rose from $4.34 to $12.92. High deductible insurance plans may result in higher costs of insulin for individuals with diabetes, too, until annual deductibles are met.