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Monthly News Round Up - September 2012

Stivarga Approved Under FDA Priority Review

The second new treatment in two months has been approved for the treatment of adults with metastatic colorectal cancer. The U.S. Food and Drug Administration (FDA) has approved Stivarga (regorafenib), an oral multi-kinase inhibitor. In a randomized, controlled trial patients treated with Stivarga plus best supportive care (BSC) lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC. In August 2012, the FDA also approved Zaltrap (ziv-aflibercept) for use in combination with FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat metastatic colorectal cancer.

New Indication for Humira: Ulcerative Colitis

Ulcerative colitis leads to intestinal inflammation, rectal bleeding and diarrhea and affects roughly 620,000 Americans. The U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) for the treatment of moderate-to-severe ulcerative colitis. In placebo-controlled trials, 16.5 to 18.5 percent of patients treated with Humira achieved clinical remission compared with 9.2 to 9.3 percent of patients receiving placebo. Additionally, 8.5 percent of patients treated with Humira sustained their clinical remission. Humira is also approved for treatment of rheumatoid, plaque or psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and juvenile idiopathic arthritis.

Genzyme’s Aubagio Approved for Multiple Sclerosis

The U.S. Food and Drug Administration (FDA) has approved Aubagio (teriflunomide) as a new once-daily, oral treatment indicated for patients with relapsing forms of multiple sclerosis (MS). Aubagio, an oral pyrimidine synthesis inhibitor, has shown significant efficacy across key measures of MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions as detected by MRI. Aubagio is an immunomodulator with anti-inflammatory properties and may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).

Bosulif Approved to Treat Chronic Myelogenous Leukemia

Bosulif (bosutinib) has been approved by the U.S. Food and Drug Administration (FDA) for patients with chronic, accelerated or blast phase Philadelphia chromosome positive chronic myelogenous leukemia (CML) who are resistant to or who cannot tolerate other therapies. Patients with CML have a genetic mutation that causes the bone marrow to make the enzyme tyrosine kinase. Tyrosine kinase triggers the development of abnormal leukocytes normally used for fighting infections. Bosulif works by blocking the enzyme signal that promotes the development of these defective white blood cells. Other drugs approved by FDA to treat various forms of CML include imatinib, dasatinib, and nilotinib.

Mylan Launches First Time Generic Diovan HCT

Mylan Pharmaceuticals has received approval for the antihypertensive agent valsartan and hydrochlorothiazide tablets (Diovan HCT) in 80/12.5, 160/12.5, 320/12.5, and 320/25 milligram strengths. The brand product Diovan HCT was ranked 36th in U.S. sales in Q2 2012 with revenues of over $400 million, but these numbers are expected to drop. Mylan also has 168 abbreviated new drug applications worth over $77 billion in annual sales pending approval. Valsartan/hydrochlorothiazide tablets are indicated for patients whose hypertension is not adequately controlled on one agent, or who might need multiple agents to control blood pressure.

Posted: September 2012