RapidRx

U.S. Food and Drug Administration (FDA) approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) 100 Units/mL & 33 mcg/mL for the treatment of adults with type 2 diabetes inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

Soliqua 100/33 is the combination of Lantus (insulin glargine 100 Units/mL) and lixisenatide, a GLP-1 receptor agonist, in a once-daily injection, studied in a Phase 3 program of more than 1,900 patients. In an insulin intensification study, Soliqua 100/33 showed better HbA1c (average blood sugar over time) lowering versus Lantus with a majority of the 736 patients (55% vs. 30%) achieving the American Diabetes Association target of less than 7% at 30 weeks. Patients treated with Soliqua 100/33 experienced similar rates of documented (less than or equal to 70 mg/dL) hypoglycemia compared to Lantus-treated patients. The most frequently reported adverse events included hypoglycemia, as well as nausea (10%), nasopharyngitis (7%), diarrhea (7%) and upper respiratory tract infection (5%).

Soliqua 100/33 will be delivered in a single pre-filled pen for once-daily dosing covering 15 to 60 Units of insulin glargine 100 Units/mL and 5 to 20 mcg of lixisenatide using SoloStar technology, the most frequently used disposable insulin injection pen platform in the world.

U.S. Food and Drug Administration (FDA) approved the New Drug Application for Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6 mg/mL injection). Xultophy 100/3.6 is a once-daily, combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8 mg of liraglutide daily.¹Xultophy 100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.

Xultophy 100/3.6 is administered as a once-daily injection from a prefilled pen and can be taken with or without food. Each Xultophy 100/3.6 dosage unit contains one unit of insulin degludec and 0.036 mg of liraglutide. The starting dose of Xultophy 100/3.6 is 16 units (16 units insulin degludec and 0.58 mg liraglutide). The maximum dose of 50 units of Xultophy 100/3.6 corresponds to 50 units of insulin degludec and 1.8 mg of liraglutide.

 

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).

During menopause, levels of estrogen decline in vaginal tissues, which may cause a condition known as VVA, leading to symptoms such as pain during sexual intercourse.

“Pain during sexual intercourse is one of the most frequent symptoms of VVA reported by postmenopausal women,” said Audrey Gassman, M.D., deputy director of the Division of Bone, Reproductive, and Urologic Products (DBRUP) in the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research (CDER). “Intrarosa provides an additional treatment option for women seeking relief of dyspareunia caused by VVA.”

Efficacy of Intrarosa, a once-daily vaginal insert, was established in two 12-week placebo-controlled clinical trials of 406 healthy postmenopausal women, 40 to 80 years of age, who identified moderate to severe pain during sexual intercourse as their most bothersome symptom of VVA. Women were randomly assigned to receive Intrarosa or a placebo vaginal insert. Intrarosa, when compared to placebo, was shown to reduce the severity of pain experienced during sexual intercourse.

The safety of Intrarosa was established in four 12-week placebo-controlled trials and one 52-week open-label trial. The most common adverse reactions were vaginal discharge and abnormal Pap smear.

Although DHEA is included in some dietary supplements, the efficacy and safety of those products have not been established for diagnosing, curing, mitigating, treating or preventing any disease.

The odds of surviving cardiac arrest seem higher for patients who’ve been taking cholesterol-lowering statins, a new study shows.

Researchers in Taiwan studied the medical records of nearly 138,000 cardiac arrest patients. Those already using statins such as Lipitor (atorvastatin) or Crestor (rosuvastatin) were about 19 percent more likely to survive to hospital admission and 47 percent more likely to be discharged. Also, they were 50 percent more likely to be alive a year later, the study found.

“When considering statin use for patients with high cholesterol, the benefit of surviving sudden cardiac arrest should also be considered, as statin use before cardiac arrest might improve outcomes of those patients,” said study author Dr. Ping-Hsun Yu.

Yu is a researcher from the National Taiwan University Hospital and College of Medicine in New Taipei City.

The greatest survival benefit from statins was seen in patients with type 2 diabetes, Yu’s team said.

Cardiac arrest is the abrupt loss of heart function. Death often occurs instantly or shortly after symptoms appear, according to the American Heart Association.

“We know that a large proportion of cardiac arrests occur due to coronary plaque rupture,” said Dr. Puneet Gandotra, director of the cardiac catheterization laboratories at Northwell Health Southside Hospital in Bay Shore, N.Y.

“This rupture leads to a snowball effect in arteries and can cause arteries to get blocked, resulting in a heart attack or cardiac arrest,” he explained.

So how might statins help?

“I feel that due to statin therapy, there is significant plaque stability and the effects of rupture are not as significant. Thus, an improvement in survival is noticed with patients on statin therapy who have cardiac arrests,” Gandotra said.

Statins are often prescribed for patients after a heart attack or stroke as a way to prevent a second cardiovascular event. However, “this does not mean that everyone should be on statin therapy,” Gandotra said.

These drugs can have side effects, such as muscle pain and weakness and higher blood sugar levels. In addition, the value of statins for preventing a first cardiac arrest or stroke is not clear, the researchers added.

Dr. Suzanne Steinbaum, director of Women’s Heart Health at Lenox Hill Hospital in New York City, said, “What we learn from studies like this is that [statins] have other benefits.

“A study like this gives me a reason to say, ‘There are more reasons for you to take a statin than just to lower your cholesterol,’ ” Steinbaum said.

For the study, Yu and colleagues divided the medical records of almost 138,000 patients according to whether they had used statins for 90 days within the year before their cardiac arrest. The researchers also accounted for gender, age, other medical problems, number of hospitalizations, post-resuscitation and other variables.

Because more than 95 percent of the patients in the study were Asian, these results might not apply to other groups or ethnic populations, Yu said.

The findings were to be presented on Sunday at the American Heart Association annual meeting, in New Orleans.