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Veltassa Clinical Trial Data

The FDA approval of Veltassa was based on a clinical development program that studied patients who are representative of people who typically experience high blood potassium levels, including people who had chronic kidney disease, or CKD, heart failure, diabetes and hypertension.

The pivotal Phase 3 OPAL-HK study showed Veltassa significantly decreased potassium levels in hyperkalemic CKD patients taking RAAS inhibitors (mean decrease of -1.01 0.03 mEq/L from baseline; p<0.001). At four weeks, 76 percent of patients had potassium levels in the target range (3.8 to <5.1 mEq/L). During the second part of the trial, patients taking Veltassa had no change in median potassium from baseline (0.00 mEq/L), whereas potassium levels significantly in creased in the placebo group (0.72 mEq/L; p<0.001).

The Phase 2 AMETHYST-DN trial evaluated use of Veltassa over 52 weeks in hyperkalemic patients with CKD and type 2 diabetes who were taking RAAS inhibitors. Throughout the year-long study, the majority of patients had potassium levels in the target range (3.8-5.0 mEq/L).

An open-label, uncontrolled, Phase 1 study evaluated Veltassas onset-of-action in 25 hyperkalemic CKD patients. The mean baseline blood potassium level was 5.9 mEq/L. A statistically significant reduction in blood potassium levels was first observed at 7 hours after the first dose. Potassium levels continued to decline during the 48-hour treatment period of the study (-0.8 mEq/L at 48 hours after the first dose).

In the clinical trials, most adverse reactions were mild to moderate. The most common adverse reactions in all trials included constipation (7.2 percent: 5.4 percent mild and 1.8 percent moderate), hypomagnesemia (low magnesium levels; 5.3 percent), diarrhea (4.8 percent), nausea (2.3 percent), abdominal discomfort (2.0 percent) and flatulence (2.0 percent).

Veltassa Availability

Veltassa is expected to be available to patients in the United States by the first week of January 2016. We are committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa. Veltassa Konnect

SM

is a centralized, comprehensive patient support center with a dedicated team of healthcare professionals and reimbursement specialists. Once Veltassa is available, this team plans to provide a variety of services to doctors and patients, including reimbursement support, co-pay assistance, a free drug program for eligible patients, and support to help patients take Veltassa as prescribed.

We have accumulated a sufficient inventory of active pharmaceutical ingredient, or API, to meet our anticipated demand for Veltassa. As previously disclosed, we have completed the validation of our commercial production process at Lanxess Corporation, through its affiliate Saltigo GmbH, our API manufacturer. We have also completed...


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