EMA Panel Backs Combo Drug for Hyperuricemia in Gout Patients

Marcia Frellick

June 29, 2018

Duzallo (Ironwood Pharmaceuticals) has been recommended for marketing for the treatment of hyperuricemia in patients with gout by the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP).

Gruenenthal GmbH is the applicant for Duzallo, which is a fixed-dose oral combination of lesinurad (Zurampic, AstraZeneca) and allopurinol (multiple brands), for treating hyperuricemia associated with gout in patients for whom target serum uric acid levels are not achieved through treatment with allopurinol and diet alone.

Duzallo contains two medicines in one pill to address both the underelimination and overproduction of uric acid.

"The most common side effects are influenza, gastro-oesophageal reflux disease, headache and increased blood creatinine," according to the committee.

The website for the medication says, "Some people taking Duzallo may have kidney problems, such as a sudden decrease in kidney function (acute kidney failure). Your healthcare provider may do blood tests to check your kidneys" while taking the drug. Other side effects are listed on the website.

According to highlights of the CHMP opinion, the drug will be available in film-coated tablets (300 mg/200 mg and 200 mg/200 mg). Lesinurad is a selective uric acid reabsorption inhibitor that inhibits uric acid transporter 1; allopurinol reduces uric acid production by inhibiting xanthine oxidase.

Detailed recommendations for using the drug will be published in the European public assessment report after marketing authorization has been granted by the European Commission.

In August 2017, the US Food and Drug Administration approved Duzallo for the treatment of hyperuricemia associated with gout.

Xeljanz Approval

In addition, the European Commission on Thursday approved tofacitinib citrate (Xeljanz, Pfizer) 5 mg twice daily BID in combination with methotrexate for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response to or who have not been able to tolerate a prior disease-modifying antirheumatic drug therapy.

The company announcement noted that Xeljanz is the first and only oral Janus kinase inhibitor to be approved in the European Union for the treatment of adults with active PsA. The disease affects from 1.5 to 3 million people in Europe.

"This approval for Xeljanz is an important milestone for the psoriatic arthritis community, who are in need of an additional oral treatment option to help manage their condition," said Frank Behrens, MD, of the rheumatology division at Goethe University and Fraunhofer IME-Translational Medicine and Pharmacology in Frankfurt, Germany.


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