FDA: New Options for Gout, Pulmonary Arterial Hypertension

Zurampic – Gout

The FDA has approved Zurampic (lesinurad) for the treatment of high levels of uric acid in the blood in patients with gout.

Zurampic is approved for use in combination with a xanthine oxidase inhibitor, which reduces production of uric acid in the body.

Zurampic assists excretion of uric acid by the kidneys through inhibition of transporter proteins involved in uric acid reabsorption.
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Its safety and efficacy was evaluated in 3 randomized, placebo-controlled studies involving 1537 participants for 12 months. Individuals taking Zurampic saw decreased levels of uric acid compared to those taking placebo.

Common side effects included headache, influenza, and gastroesophageal reflux disease.

The drug also carries a boxed warning against acute kidney failure when the drug is used without a xanthine oxidase inhibitor.

Uptravi – Pulmonary Arterial Hypertension

The FDA has approved Uptravi (selexipag) for the treatment of adults with pulmonary arterial hypertension (PAH).

Uptravi is an oral IP prostacyclin receptor agonist, and works by dilating blood vessels and decreasing elevated pressure in the vessels leading to the lungs.

The drug’s safety and efficacy were evaluated in a long-term clinical trial of 1156 particpants. Uptravi effectively reduced hospitalization rates for PAH and risk of disease progression when compared against placebo.

Side effects included headache, diarrhea, jaw pain, nausea, myalgia, and flushing.

—Michael Potts

References:

FDA. FDA approves Zurampic to treat high blood uric acid levels associated with gout [press release]. December 22, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm478791.htm.

FDA. FDA approves new orphan drug to treat pulmonary arterial hypertension [press release]. December 22, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm478599.htm.