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Weekly Drug News Round-Up: August 3, 2016

Heart Medicine Qbrelis Approved for Both Children and Adults

Qbrelis is the first approved oral solution of lisinopril Read More...

This past week the U.S. Food and Drug Administration (FDA) approved Silvergate Pharmaceutical’s Qbrelis (lisinopril), a 1 mg/mL oral solution used for the treatment of high blood pressure (hypertension) in adult and pediatric patients 6 years of age and older, as well as for adjunct therapy for heart failure and treatment of acute myocardial infarction (heart attack) in adults. The oral solution will allow for easier weight-based dosing for children. Adult patients who have trouble swallowing lisinopril tablets may also benefit from Qbrelis. Common side effects might include headache, dizziness, cough, low blood pressure, and chest pain.

Injectable Adlyxin FDA-Approved for Type 2 Diabetes

Adlyxin is classified as an incretin mimetic (GLP-1) receptor agonist Read More...

The FDA has approved Sanofi’s Adlyxin (lixisenatide), a new once-daily injectable type 2 diabetes medication. For maintenance dosing, Adlyxin will be available in a disposable pre-filled pen of 20 micrograms. Adlyxin is given at mealtime and is used alongside diet and exercise to improve blood sugar levels. In clinical studies, Adlyxin met the primary endpoint of hemoglobin A1c reduction, and the most common side effects included nausea, hypoglycemia (low blood sugar) and vomiting. Other drugs in the same class include liraglutide (Victoza), exenatide (Byetta, Bydureon) and dulaglutide (Trulicity).

Dysport Cleared for Lower Limb Spasticity in Children Two and Older

Dysport is the only FDA-approved botulinum toxin for the treatment of pediatric lower limb spasticity Read More...

This week the FDA approved Ipsen Biopharmaceutical's Dysport (abobotulinumtoxinA), an acetylcholine release inhibitor and neuromuscular blocking agent for the treatment of lower limb spasticity in pediatric patients aged two and older. In Phase III clinical studies in patients aged 2 to 17 years with lower limb spasticity due to cerebral palsy, patients received Dysport 10 units/kg/leg, Dysport 15 units/kg/leg or placebo injected into the gastrocnemius-soleus muscle complex located in the calf. At both 4 and 12-weeks, results for the co-primary efficacy endpoints were statistically significant. A majority of patients in the clinical study were eligible for retreatment between 16 and 22 weeks.

U.S. Researchers Launch Early Zika Virus Vaccine Trials

CDC is urging pregnant women and their partners to stay away from the South Florida, Miami area of Wynwood Read More...

There is no vaccine yet for infection with Zika virus that can lead to the serious birth defect microcephaly, which results in babies born with undersized heads and underdeveloped brains. In response, a potential vaccine for the Zika virus has entered early clinical trials in the U.S. to assess its safety in humans. The DNA-based vaccine contains genetic pieces of the Zika virus to evoke an immune response, developed by the U.S. National Institute of Allergy and Infectious Diseases (NIAID). Over a 44-week period, volunteers who receive the vaccine will be followed to determine safety and effectiveness. Florida health officials identified a new local Zika infection in Miami on Tuesday.

Diabetes Drug Victoza Tested in Heart Failure Patients: Study

Theoretically the GLP-1 agonist liraglutide might interact with this receptor in the heart and improve function Read More...

Conflicting results from two studies leaves the question open of whether the type 2 diabetes drug Victoza (liraglutide) may be helpful for outcomes in patients with heart failure. Data published in JAMA yesterday from a relatively small (271) and short-term (6 months) study suggests that the drug Victoza (liraglutide) doesn't appear to improve heart function in patients with advanced heart failure. However, another larger and longer (4 years) trial found that patients with type 2 diabetes and heart disease who were taking Victoza had a lower risk of death from heart disease and stroke, or from any cause, compared with placebo. More follow-up studies are needed.