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Monthly News Roundup - December 2013

Sovaldi: Breakthrough Therapy Approved for Hepatitis C Virus

The U.S. Food and Drug Administration has approved Gilead’s Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is part of a new paradigm of treatment, used in combination with ribavirin, to treat certain genotypes of HCV infection without the need for co-administration of interferon alfa. The use of interferon is often associated with intolerable side effects such as flu-like symptoms, anemia, and nausea. However, for HCVgenotype 4, interferon plus ribavirin will still be needed with Sovaldi. Sovaldi cost is $84,000 or $168,000 per 12- or 24-week treatment course, respectively, dependent upon HCV genotype.

FDA Approves Anoro Ellipta for Chronic Obstructive Pulmonary Disease

Cigarette smoking is the leading cause of COPD and is the third leading cause of death in the United States. The U.S. Food and Drug Administration (FDA) has approved Anoro Ellipta for the once-daily, long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta combines two inhaled COPD bronchodilator agents, umeclidinium bromide (UMEC), a long-acting muscarinic antagonist and vilanterol (VI), a long-acting beta2 agonist. VI is also found in a once-a-day COPD combination with fluticasone furoate (Breo). Anoro is administered using the Ellipta inhaler and is developed by GlaxoSmithkline and Theravance.

Velphoro Approved for Hyperphosphatemia

Velphoro (sucroferric oxyhydroxide) has received US Food and Drug Administration (FDA) approval for the control of serum phosphorus levels in patients with Chronic Kidney Disease (CKD) on dialysis. Hyperphosphatemia, an abnormal elevation of phosphorus levels in the blood, is a common and serious condition in CKD patients on dialysis. Velphoro is an iron-based, calcium-free, chewable phosphate binder that requires less pills per day than other phosphate binders such as sevelamer (Renagel, Renvela). The recommended starting dose of Velphoro is 3 tablets per day (1 tablet per meal). Velphoro will be launched in the US by Fresenius Medical Care North America in 2014.

Orphan Drug Tretten Approved for Rare Blood Clotting Disorder

The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Tretten (coagulation factor XIII A-Subunit recombinant) to treat an extremely rare, genetic blood clotting disorder called congenital Factor XIII A-Subunit deficiency. Patients with this deficiency do not produce enough Factor XIII, a blood protein that is important for normal clotting. Without treatment, people with Factor XIII A-Subunit deficiency are at risk for serious and life-threatening bleeding. In studies, Tretten given monthly was effective in preventing bleeding in 90 percent of the patients. No individual in the trial of 77 patients developed abnormal clots. Reported side effects include headache, pain in the extremities, and injection site pain.

Oral Orenitram Approved for Pulmonary Arterial Hypertension

At the end of December, the U.S. Food and Drug Administration (FDA) approved Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (PAH) in WHO Group I patients to improve exercise capacity. Orenitram is an oral prostacyclin analogue. In the primary efficacy study, patients that received Orenitram twice daily statistically improved their median six-minute walk distance by +23 meters as compared to patients receiving only placebo. The most common side effects reported with Orenitram are headache, nausea, and diarrhea. Orenitram contains the same active ingredient (treprostinil) as Remodulin Injection and Tyvaso Inhalation Solution.

Posted: December 2013