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Weekly Drug News Round-Up: September 13, 2017

Actelion's Tracleer Approved for Pediatric Pulmonary Hypertension

Tracleer is the first FDA-approved medication for pediatric PAH patients in the U.S. Read More...

Pulmonary arterial hypertension (PAH) is a chronic, life-threatening disorder characterized by abnormally high blood pressure in the arteries between the heart and lungs of an affected person. The U.S. Food and Drug Administration (FDA) has approved Actelion’s Tracleer (bosentan), an endothelin receptor antagonist, for use in pediatric patients aged three years and older with idiopathic or congenital PAH. A new 32 mg tablet for oral suspension will be available and can be dispersed in a teaspoon of water before oral administration. The lower dosage and score lines on the tablets are designed to allow physicians to vary the prescribed dose by the weight of the patient.

Opdivo and Yervoy: Survival in Metastatic Melanoma

Metastatic melanoma accounts for 1% of skin cancer cases but causes the majority of skin cancer deaths Read More...

A study published recently in the New England Journal of Medicine suggests that Bristol-Myers Squibb's Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor approved to treat advanced melanoma (skin cancer) is more effective than the current standard of care. In a study of 900 patients with stage III/IV melanoma who had previously undergone surgery, patients began treatment with either Opdivo or Yervoy (ipilimumab), the current standard of care, after surgery. After a year of treatment, 71% of Opdivo patients were alive without recurrence, compared to 61% in the Yervoy group. Patients taking Opdivo also had fewer severe side effects than those taking Yervoy (14% versus 45%, respectively).

Oral Hormone Supplements for Hot Flashes: Update

More data is now available from the Women's Health Initiative (WHI) studies Read More...

For years, menopausal women and their doctors have been reluctant to use oral hormone replacement therapy to treat hot flashes due to a reported increased risk of breast cancer and stroke based on the Women's Health Initiative (WHI) study. However, new data from the same study is now available. As reported this week in the Journal of the American Medical Association, women who took oral estrogen for an average of seven years or combined estrogen and progesterone therapy for an average of five years had no increased risk of death - either overall or specifically from cancer or heart disease - after 18 years of follow-up, compared with women given an inactive placebo.

New Monoclonal Antibody Under Research for Uncontrolled Asthma

Roughly 15 percent of asthma patients can't control the disease with current inhaled medications Read More…

A new study from The New England Journal of Medicine reports on an investigational biologic - tezepelumab - a monoclonal antibody from Amgen and MedImmune under study for moderate-to-severe asthma patients. Researchers studied 584 patients aged 18 to 75 with severe asthma and who were nonsmokers, and received a low-dose, medium-dose or high-dose of tezepelumab, or a placebo. Investigators found that the drug resulted in 61% to 71% fewer asthma attacks that required a hospital visit or change in medication dose compared to those who took a placebo, independent of baseline blood eosinophil counts.

AbbVie’s Investigational Rheumatoid Arthritis Agent Meets Primary Endpoints

ACR20 is a measurement showing improvement in disease activity, like tender and swollen joints, pain, and physical activity Read More...

A new investigational drug, upadacitinib (ABT-494), is an oral JAK1-selective inhibitor and may offer another treatment option for patients who do not respond to or tolerate conventional medications like DMARDs. In AbbVie’s SELECT-NEXT Phase 3 study, patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with conventional synthetic DMARDs were evaluated. At 12 weeks, 64% and 66% of patients receiving a 15 mg or 30 mg once-daily dose of upadacitinib, respectively, achieved ACR20, compared to 36 percent of patients receiving placebo, which met the study’s primary endpoints. Key secondary endpoints were also met. Upadacitinib is also being researched in Crohn’s disease.