Heart failure

FDA: Novel Heart Failure Treatment Approved

Entresto – Heart Failure

The FDA has approved Entresto (sacubitril/valsartan) for the treatment of heart failure, after being found to reduce both cardiovascular-related hospitalization and mortality. 1

The drug, which received priority review and fast track designation, was evaluated in a trial comparing its efficacy against Enalapril, another heart failure drug. Participants received either 200 mg twice daily of Entresto or 10 mg twice daily of Enalapril.

Overall, Entresto effectively reduced both cardiovascular-related mortality rates, and cardiovascular-related hospitalization—participants taking Entresto were 21% less likely to be hospitalized for heart failure than those taking Enalapril.

The most common side effects of the drug were low blood pressure, hyperkalemia, and renal impairment. Angioedema was also reported.
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Orkambi – Cystic Fibrosis

The FDA has approved Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) for the treatment of cystic fibrosis (CF) in patients with the F508del mutation (the leading cause of the disease). 2

The safety and efficacy of the drug were evaluated in 2 double-blind studies of 1108 participants with CF and the F508del mutation. Overall, participants randomized to Orkambi showed improved lung function compared to controls.

The most common side effects include shortness of breath, upper respiratory tract infection, nausea, diarrhea, and rash.  

Unapproved Prescription Ear Drops

The FDA has announced that it will take action against manufacturers of several unapproved prescription ear drop products for the treatment of ear pain, infection, and inflammation. 3

The products have been found to contain unevaluated ingredients, including benzocaine and chloroxylenol.

“The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status,“ they wrote.

Products containing the following ingredients are involved in this action:

  • benzocaine;
  • benzocaine and antipyrine;
  • benzocaine, antipyrine, and zinc acetate;
  • benzocaine, chloroxylenol, and hydrocortisone;
  • chloroxylenol and pramoxine; and
  • chloroxylenol, pramoxine, and hydrocortisone.

—Michael Potts

References:

  1. FDA. FDA approves new drug to treat heart failure [press release]. July 7, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453845.htm.
  2. FDA. FDA approves new treatment for cystic fibrosis [press release]. July 2, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453565.htm
  3. FDA. FDA takes action against unapproved prescription ear drop products [press release]. July 1, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm453348.htm