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Monthly News Roundup - April 2014

Sylvant is First FDA-Approved Drug for Multicentric Castleman’s Disease

The U.S. Food and Drug Administration (FDA) has approved Janssen Biotech’s Sylvant (siltuximab), an orphan drug for patients with multicentric Castleman’s disease (MCD). MCD is a rare disorder resembling cancer of the lymph nodes (lymphoma). Sylvant is an interleukin-6 (IL-6) antagonist that blocks a protein to help slow abnormal growth of immune cells. In clinical trials, a tumor response was seen in 34 percent of 79 participants treated with Sylvant and best supportive care (BSC), but no participant treated with placebo and BSC had a tumor response. Sylvant is used in patients who do not have HIV or human herpes virus 8.

FDA Approves Lilly’s Cyramza for Advanced Stomach Cancer

Cyramza (ramucirumab) is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated to treat patients with advanced stomach cancer or gastroesophageal junction adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. On April 21 the U.S. Food and Drug Administration (FDA) approved Cyramza based on a clinical trial of 355 participants. Those treated with Cyramza experienced a median overall survival of 5.2 months, compared to 3.8 months in participants receiving placebo. Additionally, participants who took Cyramza experienced a delay in tumor growth (progression-free survival) compared to participants who were given placebo.

GSK’s Tanzeum Approved: A Once-Weekly Injection for Type 2 Diabetes

Tanzeum (albiglutide) is a newly approved glucagon-like peptide-1 (GLP-1) receptor agonist, a hormone that helps normalize blood sugar levels in patients with type 2 diabetes. Tanzeum is given by subcutaneous (under the skin) injection, and, as with most diabetes treatments, is to be used alongside diet and exercise. The safety and effectiveness of Tanzeum was shown in eight clinical trials involving over 2,000 participants with type 2 diabetes. Tanzeum was studied alone and in use with other type 2 diabetes treatments, including metformin, glimepiride, pioglitazone, and insulin. Byetta and Victoza are other drugs in the same class as Tanzeum.

Evzio Approved for Caregiver Use in Suspected Narcotic Overdose

The U.S. Food and Drug Administration (FDA) has approved Evzio (naloxone hydrochloride) as an emergency treatment for known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of an opioid (narcotic) overdose and is the standard treatment. Evzio delivers a single naloxone dose via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. Existing naloxone drugs require administration via syringe and are most commonly used by trained medical personnel. Because naloxone may not work as long as opioids, repeat doses may be needed. Evzio provides verbal instructions when it is switched on.

Pfizer Announces Approval of Over-the-Counter Nexium 24HR

The mega-blockbuster Nexium (esomeprazole magnesium) has been approved for over-the-counter (OTC) use by the U.S. Food and Drug Administration (FDA). The newly marketed OTC - Nexium 24HR - is a proton pump inhibitor used for gastroesophageal reflux disease (GERD), otherwise known as heartburn. The prescription product Nexium is indicated for treatment of erosive esophagitis, gastroesophageal reflux disease (GERD) and for use in eradication of H. pylori to reduce the risk of duodenal (intestinal) ulcer recurrence. Nexium reaped in over $6 billion in 2013 and has long been ranked in the top 5 drugs by sales.

Posted: April 2014