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Relypsa Submits Supplemental New Drug Application to FDA Requesting Label Changes for Veltassa Based on Phase 1 Drug-Drug Interaction Studies

REDWOOD CITY, Calif., May 25, 2016 (GLOBE NEWSWIRE) -- Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that the company has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) requesting label changes for Veltassa® (patiromer) for oral suspension based on results of 12 Phase 1 drug-drug interaction studies in healthy volunteers.

“We were encouraged by the results of our Phase 1 drug-drug interaction studies, which showed no impact to absorption with any of the drugs tested when dosing with Veltassa was separated by 3 hours. In addition, there was no clinically meaningful reduction in absorption for the majority of drugs tested when they were co-administered with Veltassa,” said Lance Berman, M.D., chief medical officer of Relypsa. “We look forward to working with the FDA with the goal of updating Veltassa’s label to reflect these data.”

About the Veltassa Drug-Drug Interaction Program
Veltassa was approved by the FDA for the treatment of hyperkalemia in the United States on October 21, 2015, becoming the first new medicine in more than 50 years for people with elevated serum potassium.

The drug-drug interaction program submitted as part of Veltassa's original New Drug Application (NDA) included in vitro drug-drug interaction tests (conducted in test tubes). In these initial in vitro tests, 28 drugs were tested. Fourteen showed binding with Veltassa and 14 showed no binding.

Of the 14 drugs that did show binding in vitro, 12 were selected for further testing in healthy volunteer studies to assess whether the results seen in vitro translated into an effect in people. These Phase 1 studies showed that when Veltassa was administered at the same time as the drugs being tested, there was no clinically meaningful reduction in absorption for nine of the 12 drugs. Three drugs showed reduced absorption when they were co-administered with Veltassa, however, when dosing of Veltassa and these drugs was separated by three hours, no reduction in absorption was observed.

About Hyperkalemia
Approximately 3 million people in the United States with stage 3 or 4 chronic kidney disease (CKD) and/or heart failure have hyperkalemia, or elevated blood potassium levels. Hyperkalemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are frequently prescribed to people with CKD and heart failure to help delay progression of their underlying disease can cause hyperkalemia as a side effect. These include renin angiotensin aldosterone system (RAAS) inhibitors, such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors.

About Veltassa
Veltassa is a potassium binder approved for the treatment of hyperkalemia. Veltassa should not be used as an emergency treatment for life-threatening hyperkalemia because of its delayed onset of action.

Made in powder form consisting of smooth, spherical beads, Veltassa is mixed with water (90 milliliters or 3 ounces) and taken once-a-day with food. Veltassa is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.

IMPORTANT SAFETY INFORMATION

The Prescribing Information for Veltassa includes a Boxed Warning that Veltassa binds to many other orally administered medications, which could decrease their absorption and reduce their effectiveness. Other oral medications should be administered at least 6 hours before or 6 hours after Veltassa. Doctors should choose Veltassa or the other oral medication if adequate dosing separation is not possible.

Contraindications
Veltassa is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa or any of its components.

Worsening of Gastrointestinal Motility
Use of Veltassa should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.

Hypomagnesemia
Veltassa binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.

Adverse Reactions
The most common adverse reactions (incidence ≥2 percent) were constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa and included edema of the lips.

For additional Important Safety Information and Veltassa’s full Prescribing Information, please visit www.relypsa.com/veltassa/prescribing-information.

About Relypsa, Inc.
Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company’s first medicine, Veltassa (patiromer) for oral suspension, was developed based on Relypsa’s rich legacy in polymer science. Veltassa is approved in the United States for the treatment of hyperkalemia. Veltassa has intellectual property protection until 2030 in the United States and 2029 in the European Union. More information is available at www.relypsa.com.

Forward-Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Relypsa, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the encouraging results of the Phase 1 drug-drug interaction studies, the goal to update Veltassa’s label to reflect these data and the potential FDA approval of the supplemental New Drug Application. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development and commercialization process, including regulatory requirements, Relypsa's substantial dependence on Veltassa, Relypsa's commercialization plans and efforts and other matters that could affect the availability or commercial potential of Veltassa. Relypsa undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Relypsa in general, see Relypsa's current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2015 and its Quarterly Report on Form 10-Q for the quarterly period ended March 30, 2016.

Contact:
Charlotte Arnold
Vice President, Corporate Communications and Investor Relations
650.421.9352
IR@relypsa.com

Source:Relypsa, Inc.