News

Gout gospel, the first fixed dose combination therapy approved today

  • Author:Jane
  • Source:ZHIYAO
  • Release on :2017-08-24
Today, Ironwood Pharmaceuticals has announced that the US FDA has approved its daily oral administration of a new drug, DUZALLO, for the treatment of hyperuricemia in gout patients. These patients alone did not achieve all of the target serum uric acid (sUA) levels with allopurinol alone. Ironwood expects the drug to be available by the end of 2017.

Gout is caused by a higher serum uric acid level caused by an inflammatory arthritis that can cause pain and severe long-term health consequences. Some patients can reduce serum uric acid levels by using xanthine oxidase inhibitors (XOI) - allopurinol. But in the United States, about 2 million patients in the use of XOI treatment of the disease can not control, can not meet the American Society of Rheumatology recommended target serum uric acid level - less than 6 mg / dL. These patients urgently need a new treatment to control the condition.

DUZALLO is such a drug. It is the first therapy to combine standard drug allopurinol with FDA-approved drug lesinurad. This fixed dose combination of drugs (200 mg lesinurad +300 mg allopurinol) can provide two mechanisms by taking monoclonal drugs, while addressing the problem of excessive production and secretion of serum uric acid, which is the fundamental cause of hyperuricemia the reason.

The efficacy of DUZALLO was also confirmed in clinical trials. These two key clinical trials (CLEAR 1 and CLEAR 2) evaluated the bioequivalence of the fixed dose of lesinurad combined with allopurinol and the use of these two drugs alone. The results showed that the use of DUZALLO in the first 6 months to increase the standard of patients with nearly doubled in the first month so that the average sUA levels down to 6 mg / kg in the use of allopurinol can not achieve the target sUA levels of gout patients, DL below and maintain this level for 12 months.

"DUZALLO's approval has provided a new fixed-dose, double-mechanism treatment option for gout patients who can not achieve serum uric acid levels, which is an important and desirable treatment option for hyperuricemia," the University of Chicago "The gout is a serious and potentially progressive inflammatory disease that puts the serum uric acid in the gout patient and maintains that goal," said Dr. Michael Becker, a professor at the Faculty of Medicine. "DUZALLO can meet this Demand to help these patients who take allopurinol but can not make serum uric acid up to standard. "

"Patients who benefit from DUZALLO treatment alone will have doubled the number of gout patients who achieve target serum uric acid levels compared to patients who use allopurinol alone, which is very important, given the serious unmet needs of these patients." "Said Tom McCourt, Senior Vice President and Chief Commercial Officer, Ironwood Marketing and Sales.

Reference:

[1] Ironwood (IRWD) Announces FDA Approval Of DUZALLO (Lesinurad And Allopurinol) For The Treatment Of Hyperuricemia In Patients With Uncontrolled Gout

[2] Ironwood looks to boost gout franchise as FDA commission OK for Duzallo