FDA: New Options for Hyperkalemia, Pancreatic Cancer, Rare Bleeding Disorder
Veltassa – Hyperkalemia
The FDA has approved Veltassa (patiromer for oral suspension) for the treatment of hyperkalemia.1
Veltassa, a powder intended to be mixed with water and consumed orally, works by decreasing the absorption of potassium in the gastrointestinal tract.
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The safety and efficacy of the drug were tested in several clinical trials that found that Veltassa was effective at lowering potassium levels in patients with hyperkalemia and chronic kidney disease taking at least 1 renin-angiotensin-aldosterone inhibitor.
The most common side effect was decreased magnesium levels, diarrhea, nausea, and abdominal pain.
Coagadex – Factor X deficiency
The FDA has approved Coagadex for the treatment of patients with hereditary Factor X deficiency. It is the first drug available for the treatment of patients with this rare bleeding disorder.2
Patients with Factor X deficiency are normally treated with fresh-frozen plasma or with plasma-derived prothrombin complex concentrates. Coagadex, which is derived from human plasma, is indicated for on-demand treatment and control of bleeding episodes and perioperative management of bleeding.
The drug’s safety and efficacy were tested in a multi-center non-randomized study of 16 participants with the rare blood disorder. Coagadex effectively manage episodes of bleeding in patients with moderate to severe Factor X deficiency. It was also shown to be effective at controlling blood loss during sugery in 5 participants with moderate or severe Factor X deficiency.
Onivyde – Pancreatic Cancer
The FDA has approved Onivyde (irinotecan liposome injection) for the treatment of patients with advanced pancreatic cancer who have been treated with gemcitabine-based chemotherapy. The drug is to be used in combination with fluorouracil and leucovorin.3
The effectiveness of the drug was evaluated in a 3-arm, randomized, open label study of 417 participants with metastatic pancreatic adenocarcinoma with tumors that had grown after treatment with gemcitabine. Patients treated with Onivyde lived an average of 6.1 months compared to 4.2 months for those treated with fluorouracil/leucovorin alone.
The safty of the drug was evaluated in a study of 398 patients who received either Onivyde plus fluorouracil/leucovorin, fluorouracil/leucovorin alone, or Onivyde alone.
Common side effects included diarrhea, fatigue, vomiting, nausea, stomatitis, and fever.
—Michael Potts
References:
- FDA. FDA approves new drug to treat hyperkalemia [press release]. October 22, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468546.htm.
- FDA. FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder [press release]. October 20, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468038.htm.
- FDA. FDA approves new treatment for advanced pancreatic cancer [press release]. October 22, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468654.htm.