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Weekly Drug News Round-Up: November 22, 2017

FDA Approves Juluca, a Novel 2-Drug Regimen for HIV-1 Infection

Juluca is the first complete treatment regimen containing only two drugs, instead of three or more, for HIV maintenance Read More...

The U.S. Food and Drug Administration (FDA) has approved ViiV Healthcare’s Juluca (dolutegravir and rilpivirine), a single-tablet, fixed-dose, two-drug regimen of the approved drugs dolutegravir (Tivicay) and rilpivirine (Edurant). Juluca is used in certain adults with suppressed HIV-1 virus on a stable medication regimen for at least six months, with no history of treatment failure and no resistance to the individual components of Juluca. In clinical trials, Juluca was effective in keeping the virus suppressed and comparable to those who continued their current anti-HIV drugs. The most common side effects in patients taking Juluca were diarrhea and headache. Learn more about new HIV-1 virus treatments.

First-In-Class Hemlibra is Cleared for Hemophilia A with Inhibitors

Hemophilia A is an inherited blood-clotting disorder that primarily affects males Read More...

Hemlibra (emicizumab-kxwh), from Genentech, is a bispecific factor IXa- and factor X-directed antibody now approved to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed antibodies called Factor VIII (FVIII) inhibitors. The new agent is a first-in-class therapy that works by bridging other Factors in the blood to restore blood clotting. In two clinical studies, there was an 87 percent reduction in the rate of bleeds that needed treatment. Hemlibra is given weekly via injection under the skin (subcutaneous). Common side effects of Hemlibra include injection site reactions, headache, and joint pain (arthralgia).

Mepsevii First Approved Drug for Mucopolysaccharidosis (MPS) Type VII

MPS VII is an inherited, rare genetic condition with various skeletal and organ abnormalities, and possible intellectual disability Read More...

After submitting their application via a Fast Track FDA designation, Ultragenyx Pharmaceuticals received approval Mepsevii (vestronidase alfa-vjbk) to treat pediatric and adult patients with an inherited metabolic condition called mucopolysaccharidosis type VII (MPS VII), also known as Sly syndrome. Safety and efficacy was demonstrated via clinical trials and expanded access in 23 patients ranging from 5 months to 25 years. Positive results with Mepsevii were seen in some patients with the six-minute walk test and improvement in pulmonary function. The most common side effects include infusion site reactions, diarrhea, rash and anaphylaxis (a severe allergic reaction).

FDA Expands Sutent Use: Adjuvant Treatment for Kidney Cancer

Adjuvant treatment is used after an initial surgical removal of the cancer to lower the risk of recurrence Read More...

Pfizer’s Sutent (sunitinib malate), an oral kinase inhibitor, has been FDA- approved as adjuvant treatment of patients at high risk of recurrent renal cell carcinoma (kidney cancer) following nephrectomy (kidney removal). Sutent is also approved for tumors of the gastrointestinal tract and pancreas, as well as treatment of advanced renal cell carcinoma. In a study of 615 patients, 59.3% of patients treated with Sutent had not experienced cancer recurrence or death after 5 years compared with 51.3% of patients receiving placebo. Common side effects of Sutent include fatigue, diarrhea, inflammation of the mucous membranes and inside the mouth, and nausea, among others.

Tekturna Oral Pellets OK’d for High Blood Pressure in Peds and Adults 

According to the American Academy of Pediatrics, the prevalence of clinical hypertension in children is roughly 3.5% Read More...

The FDA has approved Noden Pharma’s Tekturna (aliskiren) Oral Pellets for the treatment of hypertension (high blood pressure) in adults and children 6 years of age and older. Tekturna (aliskiren) is a once-daily, direct renin inhibitor. In studies, hypertensive patients 6 to 17 years were followed in an 8-week randomized study, including 52 weeks of follow-up. Tekturna reduced both systolic and diastolic blood pressure and is dosed dependent upon weight; no unanticipated adverse reactions occurred. Tekturna Oral Pellets should be emptied from the capsule into a spoon and swallowed immediately without chewing. It can also be mixed with specific dosing vehicles (vanilla pudding or vanilla ice cream, milk, or water).