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And other news from the US Food and Drug Administration
January 2016, Vol 4, No 1 - Inside Drug Update

New Drugs

The following are recent approvals announced by the US Food and Drug Administration (FDA):

  • Zurampic (lesinurad) has been approved by the FDA for patients with gout who have hyperuricemia, in combination with xanthine oxidase inhibitor (XOI), a drug that reduces the production of uric acid. This approval was based on safety and efficacy data of 3 randomized, placebo-controlled trials with 1537 patients treated with lesinurad in combination with XOI for ≤12 months. Patients in the treatment group had a reduction in their uric acid levels, compared with the placebo group. Healthcare providers should be aware that lesinurad has a boxed warning with impor­tant safety information, including risk for renal failure, which is more common when lesinurad is used without an XOI and at higher-than-approved doses.
  • Uptravi (selexipag), a new orphan drug for adults with pulmonary arterial hypertension, has been approved by the FDA. The mechanism of action of selexipag involves the relaxation of muscles in the walls of blood vessels to dilate blood vessels and decrease elevated pressure in the vessels supplying blood to the lungs. Selexipag is part of a class of drugs called oral IP prostacyclin receptor agonists. The approval was based on safety and efficacy data evaluated as part of a long-term clinical trial including 1156 patients with pulmonary arterial hypertension. Patients treated with selexipag (median duration, 1.4 years) had a reduction in hospitalization for pulmonary arterial hypertension and risk for disease progression, compared with placebo. Headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in an extremity, and flushing were common side effects observed in patients treated with selexipag.

Announcements

  • The FDA recently released an announcement about improving hearing aid usage and innovation. In particular, they are looking to renew their efforts to better understand how their agency can appropriately balance patient safety with encouraging advancements in, as well as access to, hearing aid technology in the United States.
  • In addition, it was recently announced by the FDA that they are updating the blood donor referral policy to reflect the most current scientific evidence, and will continue to ensure the safety of the US blood supply by reducing human immunodeficiency virus transmission risks via blood and blood products. Specifically, the FDA is changing its recommendation of indefinite referral for men who have sex with men to 12 months since the last sexual contact with another man.



  1. US Food and Drug Administration. Press announcements. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements. Updated January 7, 2016. Accessed January 7, 2016.
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