Drug Update: April 2016 Issue 1

FDA Drug Review News

FDA Approves Zurampic® (lesinurad) for Adjunctive Treatment of Gout

In December 2015, Zurampic was FDA-approved to be used in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia in patients with gout who had not achieved target serum uric acid levels. Zurampic reduces serum uric acid levels by inhibiting the function of transporter proteins (URAT1 and OAT4), which are involved in uric acid reabsorption in the kidneys.

The recommended daily dose of Zurampic is 200 mg. It should be taken with food and always be co-administered with a xanthine oxidase inhibitor, such as allopurinol or Uloric® (febuxostat). The use of Zurampic is not recommended for patients taking less than 300 mg of allopurinol daily. Zurampic contains a Black Box Warning that states “acute renal failure has occurred with Zurampic, especially when given as monotherapy.”

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Drug Update: March 2016 Issue 2

FDA Drug Review News

U.S. Food and Drug Administration Expands Indication for Cancer Drug Imbruvica®

In March 2016, the U.S. Food and Drug Administration (FDA) approved Imbruvica® (ibrutinib) as first-line treatment for patients with chronic lymphocytic leukemia (CLL) regardless of treatment history (treatment-naïve or previously-treated). This approval marks the 5th treatment indication for Imbruvica, and the first FDA-approved chemotherapy-free treatment option for first-line CLL patients. Imbruvica is also approved for treating high-risk CLL patients with the 17p deletion mutation, patients with mantle cell lymphoma (MCL) who have received at least one previous therapy, and patients with Waldenstrom’s macroglobulinemia. Read more

Drug Update: March 2016 Issue 1

FDA Approves Briviact® (brivaracetam) for Treatment of Partial Onset Seizures

The US Food and Drug Administration (FDA) approved Briviact (brivaracetam) on February 19, 2016. It is a selective, high-affinity synaptic vesicle protein 2A ligand and an analogue of the antiepileptic drug levetiracetam. Briviact is indicated as add-on therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy.
Epilepsy is a common disorder affecting more than 5 million people in the US. It can cause a variety of symptoms including uncontrolled movements or spasms, abnormal thoughts and behaviors, and abnormal sensations. These muscle spasms can be violent and may lead to loss of consciousness. Seizures are caused by uncontrolled activation of neurons in the brain. Partial onset seizures originate within a limited area of the brain.

Briviact’s effectiveness was studied in three clinical trials, which included more than 1,500 participants. When taken as an adjunct to other medications, Briviact was shown to be effective in reducing the frequency of seizures. Read more