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Weekly Drug News Round-Up: January 4, 2017

Shire Announces Approval of Adynovate for Younger Children

Adynovate exhibits an extended circulating half-life and is dosed twice-weekly for hemophilia A Read More…

Last week the U.S. Food and Drug Administration (FDA) approved Shire’s Adynovate [Antihemophilic Factor (Recombinant), PEGylated], for treatment of hemophilia A in patients under 12 years of age. The FDA also approved Adynovate for use in surgical settings for both adult and pediatric patients. In Phase 3 studies in children under 12 years, Adynovate met its primary endpoint with no previously treated children having developed inhibitory antibodies to Adynovate. About 70 percent of children had zero joint bleeds (n=48/66) while on prophylactic treatment with Adynovate and roughly 40 percent experienced zero bleeds (n= 25/66). The most common side effects were nausea and headache.

Guidelines Confirm Metformin Best Initial Choice for Type 2 Diabetes

Roughly 29 million people in the United States have diabetes Read More...

Metformin (Glumetza, Glucophage, and Fortamet) has been the go-to first-line agent for type 2 diabetes treatment to lower blood sugars, and guidelines out this week reaffirm that fact. Published in the Annals of Internal Medicine, the recommendations come from the American College of Physicians (ACP). Compared to other treatments, metformin is more effective, cheaper due to generic availability, and has less side effects. The ACP recommends that if a patient needs a second drug to lower blood sugar levels, options to discuss include sulfonylurea such as glyburide (Diabeta), thiazolidinedione like pioglitazone (Actos), SGLT-2 inhibitor like canagliflozin (Invokana), or a DPP-4 inhibitor such as sitagliptin (Janumet, Januvia).

Investigational Parkinson's Drug May Lessen "Off-Time"

Common problems with movement in Parkinson’s disease patients include tremors, stiffness, and slowed movement Read More...

Levodopa-carbidopa (Sinemet) is a standard oral treatment for Parkinson’s disease, but over the long-term levodopa effectiveness can wane leading to “off-time” or worsened involuntary movements. However, an investigational oral drug known as opicapone (Ongentys), a COMT enzyme inhibitor, appears to be an improvement over current treatment options and boosts levodopa's ability to control the motor difficulties. As published in JAMA Neurology, researchers noted people taking the higher-dose version of opicapone in studies achieved a "significant reduction" in the amount of time levodopa failed to work. Common side effects with opicapone included movement problems (dyskinesia), constipation, and dry mouth.

Minors Can Easily Buy Bodybuilding Supplements Meant for Adults

Creatine is a naturally occurring amino acid that's found in meat and fish and made by the body Read More...

The American Academy of Pediatrics and the American College of Sports Medicine advise against use of creatine in people younger than 18, and the products are specifically labeled that way. However, in a recent study, a researcher posing as a 15-year old football player reported that over two-thirds of sales attendants at health food stores across the nation recommended creatine. While creatine is promoted to build lean body mass, it can lead to dehydration and damage the kidneys and liver over the long-term, a concern for still-developing teens. Clinicians suggest people interested in taking supplements should always talk to their doctor or nutritionist first.

2016 New Drug Approvals: The Year That Was

Review the 2016 end-of-year slideshow to see the FDA approval history and future new drug predictions Read More...

The year has ended, but what new and important approvals made their debut? Significant medical conditions all had major winners: viral hepatitis C (Zepatier, Epclusa), HIV (Odefsey, Descovy) and psoriasis (Taltz). Plus, biosimilars surged ahead with three new approvals of Inflectra, Erelzi and Amjevita. Tecentriq, the first available PD-L1 immune checkpoint inhibitor, gained two new cancer uses, and FDA cleared Clovis Oncology's Rubraca (rucaparib) for the treatment of advanced mutant BRCA ovarian cancer. Although many other crucial drugs were approved in 2016, the numbers were down compared to past years. So what’s on tap for new drug approvals in 2017 -- and will the pace pick back up?