Monthly News Round Up - January 2013
Genzyme’s Kynamro Approved to Treat Inherited Cholesterol Disorder
The U.S. Food and Drug Administration has approved Kynamro (mipomersen sodium) injection, an orphan drug used to treat patients with a rare and often fatal type of high cholesterol called homozygous familial hypercholesterolemia (HoFH). HoFH, an inherited condition that affects about one out of every one million people in the U.S. Kynamro is used in conjunction with other lipid-lowering medications and diet to reduce low-density lipoprotein-cholesterol (LDL-C), apolipoprotein B, total cholesterol, and other lipids. In a trial of 51 patients, levels of LDL-C fell by 25 percent during the first 26 weeks. Juxtapid (lomitapide) was also approved for HoFH in December of 2012.
New Diabetes Compound Alogliptin Approved in Three Formulations
Takeda Pharmaceutical Co. received three drug approvals with their new type 2 diabetes drug alogliptin. Alogliptin was approved in the stand-alone form (Nesina), and in combination with metformin (Kazano), and pioglitazone (Oseni). Metformin, a biguanide, is an oral, first-line type 2 diabetes treatment that has been on the U.S. market since 1995. Pioglitazone (Actos), a thiazolidinedione, is also made by Takeda, but the Actos patent expired in 3Q 2012, opening the door for generic competition. Osenia’s label contains a boxed warning due to the potential of pioglitazone to cause or exacerbate congestive heart failure.
Oxytrol for Women: First OTC Patch for Overactive Bladder in Women
The U.S. Food and Drug Administration (FDA) has approved the first over-the-counter (OTC) treatment for overactive bladder in women. Merck’s Oxytrol (oxybutynin) for Women is a transdermal skin patch applied once every four days and is used to modify symptoms such as frequent or urgent urination, incontinence (urine leakage), and increased nighttime urination. Oxytrol for Women contains an anticholinergic medication known as oxybutynin that helps to relax the bladder muscle to control symptoms. Oxybutynin tablets have already been available by prescription for overactive bladder. Prescription Botox (onabotulinumtoxinA) was also approved earlier this month for the treatment of overactive bladder.
Sirturo Approved to Treat Multi-Drug Resistant Tuberculosis
Sirturo (bedaquiline) has been approved to treat adults with multidrug resistant pulmonary tuberculosis (TB) when other alternatives are not available. Close to nine million people globally contracted TB in 2011. TB is a contagious lung disease spread via respiratory droplets from person-to-person. Multi-drug resistant TB occurs when M. tuberculosis becomes resistant to isoniazid and rifampin, two drugs most commonly used to treat TB. Sirturo should be used in combination with other drugs used to treat TB. Sirturo contains a Boxed Warning stating the drug can affect QT prolongation and may lead to abnormal heart rhythms.
Fulyzaq: Botanical Anti-Diarrheal Drug Approved for HIV/AIDS Patients
Watery diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients stop or switch their AIDS medications (antiretroviral therapies). The U.S. Food and Drug Administration (FDA) has approved Fulyzaq (crofelemer) to treat diarrhea in HIV/AIDS patients taking antiretroviral therapy. Fulyzaq is the first anti-diarrheal drug approved for HIV/AIDS patients, but should not be used for diarrhea due to an infection. In clinical trials, 374 HIV-positive patients received Fulyzaq or placebo twice a day. Results showed that 17.6 percent of patients taking Fulyzaq experienced two or fewer watery bowel movements weekly compared with 8 percent taking placebo.
Posted: January 2013