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Weekly Drug News Round Up - April 9, 2014

Evzio Approved for Caregiver Use in Suspected Narcotic Overdose

Drug overdose deaths, including prescription painkillers, are now the leading cause of injury death in the United States Read More...

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. When Evzio is turned on, it provides verbal instructions to the user.

Pradaxa Approved for Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE)

Approval is based on results from four Phase III studies Read More...

The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral (injectable) anticoagulant for 5 to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated. Standard care of patients with DVT or PE has been parenteral anticoagulation therapy, such as low-molecular-weight heparin, followed by long-term treatment with warfarin. Pradaxa is also approved to reduce the risk of stroke in patients with non-valvular atrial fibrillation.

FDA Advisory Committee Stands Behind Afrezza

If approved, Afrezza would be the first ultra rapid-acting mealtime insulin therapy available in the U.S. Read More...

A U.S. Food and Drug Administration (FDA) Advisory Committee has recommended that MannKind Corporation’s Afrezza (insulin human [rDNA origin]) Inhalation Powder be approved to treat adults with type 1 or type 2 diabetes. Afrezza Inhalation Powder is delivered using a small inhaler device and is administered at the start of a meal. Peak insulin levels are achieved within 12 to 15 minutes of administration, compared to 45 to 90 minutes for injected rapid-acting insulin analogs and 90 to 150 minutes for injected regular human insulin. The FDA was expected to make a final approval decision on Afrezza by April 15, 2014, but that date has now been extended by three months to July 15, 2014 in order to provide time for a full review of information.

Kalbitor HAE Indication Expanded to Include Patients 12 Years and Older

HAE is a rare acute inflammatory condition caused by low levels of a molecule that inhibits kallikrein, a key mediator of inflammation Read More...

The U.S. Food and Drug Administration (FDA) has approved a broader indication for Kalbitor (ecallantide) to include patients 12 years of age and older. Kalbitor is a peptide inhibitor of plasma kallikrein used in the treatment of acute hereditary angioedema (HAE) attacks. Kalbitor is the first subcutaneous therapy available to treat HAE in patients 12 years of age and older. Previously Kalbitor was approved in patients 16 years and up. HAE causes swelling, particularly of the face and airways, and abdominal cramping. Other drugs approved to treat HAE include Firazyr, Berinert, and Cinryze.

Experimental Cancer Drug Shows Early Promise for Advanced Melanoma

Melanoma is an uncommon, but often deadly, form of skin cancer Read More...

An experimental immunotherapy cancer drug, Immunocore’s IMCgp100, has shown early promise for advanced cases of melanoma skin cancer. The study size was small -- only 31 patients -- but researchers were encouraged by initial results of manageable side effects and tumor size reduction in 4 patients. Experts state it encouraging to see results like tumor shrinkage in early stage trials. The most common side effects included rash, fever and "tumor flare" -- swelling and tenderness at the site of a tumor. In 2011, an immunotherapy drug called ipilimumab (Yervoy) was approved -- the first treatment shown to prolong the lives of some patients with advanced melanoma.

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