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Weekly Drug News Round-Up: January 20, 2016

Cosentyx Gains Two New Indications

Cosentyx is a monoclonal antibody and interleukin-17A (IL-17A) antagonist Read More...

In January 2015, Novartis’ Cosentyx (secukinumab) was FDA-approved to treat moderate to severe plaque psoriasis. This past week, the FDA approved two new adult indications for Cosentyx: active ankylosing spondylitis (AS) and active psoriatic arthritis (PsA). Cosentyx underwent Phase III clinical studies evaluating both safety and effectiveness for both AS and PsA. Cosentyx met the primary endpoints with standard tools used to assess AS and PsA: a 20% improvement in the Assessment of Spondyloarthritis International Society criteria (ASAS20) at Week 16 and a 20% reduction in the American College of Rheumatology (ACR20) response criteria at Week 24, respectively.

Arzerra Approved for Recurrent or Progressive Chronic Lymphocytic Leukemia (CLL)

CLL accounts for approximately 1 in 4 cases of leukemia Read More…

Genmab A/S and Novartis announce FDA approval of a supplemental use for the biologic Arzerra (ofatumumab) for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL). In an interim analysis of 474 patients from a Phase III study, median progression free survival (PFS), the primary endpoint, was 29.4 months for the ofatumumab treatment arm and 15.2 months for the observation arm. The most common side effects (10% or greater) were infusion reactions, neutropenia, and upper respiratory tract infection.

Experts Publish Guidelines to Help Combat Antibiotic Resistance

Excessive antibiotic use is fueling antibiotic resistance

You may be aware by now that it’s cough and cold season. But experts are reminding everyone that antibiotics do absolutely no good when it comes to shortening these viral illnesses, which includes the common cold, bronchitis, sore throat or sinus infection. In the medical journal the Annals of Internal Medicine , the American College of Physicians and the CDC have published new guidelines to address antibiotic overuse. Inappropriate and widespread use of antibiotics for viral illnesses also boosts the rates of antibiotic resistance. These groups state that roughly 50 percent of antibiotic prescriptions may be unnecessary and lead to over $3 billion in excess costs.

Blood Test Might Predict When Antibiotics Could Work, Or Not

Patient often demand antibiotics even when they don’t need one Read More...

If you have a viral cough, you don't need an antibiotic. But if that cough turns into bacterial pneumonia, you might. Now, a blood test under development may be able to predict when antibiotics could work - or not - for an infection. Researchers at Duke University say distinguishing between a viral and bacterial infection can help to target the appropriate treatment, as antibiotics work for bacterial infections but not viruses. Experts state about three-quarters of patients get bacteria-fighting antibiotics even though most have viral infections. And just this week, the ACP and CDC released guidelines to help combat the antibiotic resistance epidemic.

Emverm Chewable Tablets Approved for Parasitic Worms

Pinworm infection is three times more common than head lice Read More...

Impax Laboratories has received FDA-approval of Emverm (mebendazole) 100 mg chewable tablets for the treatment of Enterobius vermicularis (pinworm), Trichuris trichiura (whipworm), Ascaris lumbricoides (common roundworm), Ancylostoma duodenale (common hookworm), and americanus (American hookworm) in single or mixed infection. Pinworms are a highly contagious parasite that infects approximately 40 million people in the US annually. Impax is expected to initiate commercial distribution of Emverm early in the second quarter of 2016.