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Weekly Drug News Round-Up: September 21, 2016

Exondys 51 is First Drug Approved for Duchenne Muscular Dystrophy

The most common side effects reported in studies to-date were balance disorder and vomiting Read More...

Duchenne Muscular Dystrophy is the most common childhood form of muscular dystrophy and is caused by a mutation in the dystrophin gene. This week, the US Food and Drug Administration (FDA) approved Exondys 51 (eteplirsen), specifically indicated for patients who have a confirmed mutation of the dystrophin gene amenable to exon 51 skipping, which affects about 13 percent of the population with DMD. Exondys 51 is classified as a morpholino antisense oligomer, and was approved under the FDA accelerated approval pathway for serious or life-threatening diseases. Additional studies will be conducted by the manufacturer, Sarepta Therapeutics, to fully confirm the drug’s clinical benefit.

Yosprala Wins FDA Approval to Lower Cardiovascular Risk

Yosprala is expected to launch into the US market the first week of October Read More...

Once-daily Yosprala (aspirin and omeprazole) from Aralez Pharmaceuticals is now FDA approved for patients who require aspirin for secondary prevention of heart attack or stroke and who are at risk of developing gastric (stomach) ulcers due to aspirin use. Yosprala first delivers immediate-release omeprazole (40 mg) followed by a delayed-release, enteric-coated aspirin core in either 81 mg or 325 mg dose strengths. The enteric-coated aspirin dissolves after the stomach pH reaches 5.5 or greater to reduce ulcer risk. Studies have shown that patients who stop cardioprotective aspirin due to a stomach bleed increase their risk of a cardiovascular event or death by almost 7-fold.

Shire Announces FDA Approval of Cuvitru for Primary Immunodeficiency

Worldwide, as many as 6 million children and adults may be affected by primary immunodeficiency, a genetic disorder Read More...

Primary Immunodeficiency (PI) Syndrome results in a weak immune system and low levels of immune globulins that act as antibodies against an infection. This can put the patient at risk for infections and recovery may be difficult. The FDA has now granted approval for Cuvitru [Immune Globulin (IG) Subcutaneous (Human), 20% Solution] in patients two years of age and older. Cuvitru 20% offers an advantage because a larger volume can be more quickly infused, resulting in fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments. Shire expects to launch Cuvitru in the U.S. in the coming weeks.

Codeine Too Risky for Kids, Doctors Warn

Codeine already had a boxed warning against use in children, but doctors have been slow to adopt this recommendation Read More...

The American Academy of Pediatrics (AAP) now report that codeine is no safer than any other narcotic for children and should not be given to them. Codeine, often used for pain and coughs, is converted by the liver into morphine, but genetic differences between people can prompt the liver to create too much morphine in some and too little in others, unpredictably. Children who are “rapid” liver metabolizers of codeine can experience severely slowed, possibly fatal, breathing rates. However, over-the-counter cough syrups are still available without a prescription from the pharmacy in 28 states and the District of Columbia. FDA data show that there were 10 child deaths due to codeine between 1969 and 2012.

Gonorrhea Shown Resistant to Standard Dual Antibiotic Regimen

Gonorrhea is a bacterial infection spread through unprotected vaginal, anal and oral sex Read More...

Data published by the US Centers for Disease Control and Prevention (CDC) earlier this year showed evidence of growing azithromycin (Zithromax) resistance in gonorrhea samples found across the nation, but those infections were still susceptible to ceftriaxone (Rocephin). Ceftriaxone, a third-generation cephalosporin, and azithromycin, from the macrolide class, are the dual antibiotic agents recommended to treat gonorrhea. However, today the CDC stated that recent samples from Hawaii are showing both azithromycin and ceftriaxone resistance for the first time. Researchers from Louisiana State University report development of an investigational antibiotic known as ETX0914 that might replace ceftriaxone, if FDA-approved.