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Monthly News Round Up - July 2013

Fetzima: A New SNRI Approved for Depression in Adults

Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor (SNRI) has been FDA-approved for treatment of Major Depressive Disorder (MDD) in adults. Levomilnacipran is the active enantiomer of milnacipran (Savella) which is approved only for fibromyalgia. In three, Phase III studies of adults with MDD, a statistically significant improvement in depression was seen for the three dosage strengths of 40, 80, and 120 mg once daily compared with placebo. Common side effects occurring in greater than 5 percent of patients included nausea, constipation, and sweating. Forest Labs expects Fetzima to be available to retail stores in 4th quarter 2013.

American Regent Receives Approval for Injectafer

The U.S. Food and Drug Administration (FDA) has approved Injectafer (ferric carboxymaltose injection). Injectafer is an intravenous (IV) iron replacement product used to treat iron deficiency anemia (IDA) in adults who cannot tolerate or did not have a satisfactory response to oral iron products and for patients with non-dialysis dependent chronic kidney disease. Injectafer is the first non-dextran IV iron approved for the treatment of adult patients with IDA. Injectafer is given as a single dose of up to 750 mg of iron via an IV push or infusion followed by a second dose seven days later for a total treatment of up to 1500 mg of iron.

Simponi Aria Infusion Approved for Rheumatoid Arthritis

The U.S. Food and Drug Administration (FDA) has approved a new formulation, Simponi Aria (golimumab) for Infusion, for the treatment of patients with moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate. Simponi Aria, a human anti-tumor necrosis factor (TNF)-alpha that reduces inflammation, is given over a 30-minute intravenous (IV) infusion period at weeks 0 and 4, then every 8 weeks thereafter. In the Phase 3 GO-FURTHER trial, a significant improvement in signs, symptoms and physical function was seen at week 24, and inhibition of the progression of structural damage was noted at weeks 24 and 52.

Astagraf XL Approved To Prevent Kidney Transplant Rejection

The U.S. Food and Drug Administration (FDA) has approved Astagraf XL (tacrolimus extended-release capsules), an immunosuppressive to be used as part of a regimen for the prophylaxis (prevention) of organ rejection in kidney transplant recipients. Astagraf XL should be used in combination with mycophenolate mofetil (Cellcept) and corticosteroids, with or without basiliximab (Simulect) induction. Astagraf XL is not for use with cyclosporine (Neoral, Sandimmune, Gengraf). The most common side effects seen with Astagraf XL include diarrhea, constipation, nausea, swelling of the hands, ankles or legs, tremors (shaking of the body) or low red blood cell count (anemia).

Gilotrif Approved for Lung Cancer After FDA Priority Review

Gilotrif (afatinib), a kinase inhibitor indicated for the treatment of patients with late-stage (metastatic) non-small cell lung cancer (NSCLC), has been FDA-approved after a priority review. Gilotrif is approved for patients whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. In the Gilotrif clinical trial, patients receiving Gilotrif had a delay in tumor growth (progression-free survival) that was 4.2 months longer than those receiving the chemotherapy drugs pemetrexed and cisplatin -- there was no difference in overall survival time. This past May, the FDA also approved Tarceva (erlotinib) for first-line treatment of patients with NSCLC.

Zubsolv Approved for Maintenance Treatment of Opioid Dependence

Opioid dependence greatly impacts the U.S. economy, with about $56 billion spent on the disease per year and almost 17,000 annual deaths from opioid pain relievers. The U.S. Food and Drug Administration (FDA) has approved Orexo’s Zubsolv (buprenorphine/naloxone) as a maintenance treatment for opioid dependence. Zubsolv is a once-daily, sublingual tablet that dissolves under the tongue. Zubsolv has higher bioavailability, faster dissolve time, and a menthol taste. The drug competes with Suboxone, Revia and Vivitrol to help patients beat addiction to painkillers. Sublingual buprenorphine/naloxone is also available generically.

Posted: July 2013