Tomorrow is the FDA's action date for its review of Relypsa's (RLYP -0.8%) New Drug Application (NDA) for Patiromer for Oral Suspension (Patiromer FOS) for the treatment of hyperkalemia (abnormal elevation in serum potassium). If approved, it will be the first new therapeutic approved for hyperkalemia in over 50 years. The condition affects people with chronic kidney disease, hypertension, diabetes and heart failure.
The FDA accepted the NDA for review in mid-December 2014. The agency communicated to the company that it did not plan to convene an advisory committee meeting for advice on the filing.
Patiromer FOS will be co-promoted by Relypsa and Sanofi (SNY -1.5%).
Previously: Relypsa to use Sanofi's sales force to help it promote Patiromer FOS (Aug. 12)
Previously: FDA sets PDUFA date for Patiromer FOS (Jan. 5)
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