FDA Roundup: New Options for Right Heart Failure, Waldenström’s, GERD
Impella RP System – Heart Pump
The FDA has approved the Impella RP System, the first percutaneous single-access heart pump designed for right heart support.1
The system is designed to provide increase blood flow from the right side of the heart for 2 weeks in patients who develop right heart failure after myocardial infarction, heart transplant, or open-heart surgery.
In a study of the system’s safety, researchers recorded a survival rate of 73% of 30 patients with right ventricular failure implanted with the Impella RP System after a period of 30 days.
“With the ability to place this device percutaneously on the right side, physicians can now treat acute right sided heart failure minimally invasively and quickly," the researchers concluded.
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Imbruvica – Waldenström’s Macroglobulinemia
The FDA has approved the use of Imbruvica (ibrutinib) for the use in patients with Waldenström’s macroglobulinemia (WM), a rare form of non-Hodgkin lymphoma.2
Imbruvica works by blocking the enzyme that causes abnormal B lymphocytes to grow within patients’ bone marrow, lymph nodes, and liver.
The drug was originally granted separate approval for treatment of patients with both mantle cell lymphoma and chronic lymphocytic leukemia in November 2013 and July 2014.
In a clinical study of 63 patients receiving 420 milligrams of Imbruvica daily, 62% of participants’ cancer shrunk after treatment. Duration of response ranged from 2.8 months to 18.8 months.
The most common side effects include low blood platelet counts, decrease in white blood cells, diarrhea, decrease in red blood cells, lack of energy, bruising, upper respiratory infection, and rash.
Esomeprazole Magnesium Delayed-Release Capsules – GERD
The FDA has approved the first generic of Nexium (esomeprazole magnesium delayed-release capsules), for the treatment of gastroesophageal reflux disease (GERD).3
Esomeprazole, a proton pump inhibitor, works by reducing the amount of acid in the stomach, preventing acids from coming back up into the esophagus.
The most common side effects of esomeprazole include headache, diarrhea, nausea, abdominal pain, sleepiness, and dry mouth.
- Abiomed. Abiomed receives fda hde approval for the impella rp first fda approved percutaneous single access heart pump designed for right heart support [press release]. http://investors.abiomed.com/releasedetail.cfm?ReleaseID=893135. Accessed January 30, 2015.
- FDA. FDA expands approved use of Imbruvica for rare form of non-Hodgkin lymphoma [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm432123.htm. Accessed January 30, 2015.
- FDA. FDA approves first generic esomeprazole [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431648.htm. Accessed January 30, 2015.