FDA Decisions Due on Four NDAs

Last week was a busy one for FDA reviewers, with decisions due on four NDAs for drugs to treat hyperkalemia, chronic pain and cancer.

PDUFA action dates were set for Wednesday for Relypsa’s potassium-lowering patiromer, Friday for BioDelivery Sciences and Endo’s Belbuca and Spectrum and Ligand’s Evomela, and Saturday for Merrimack’s MM-398.

Patiromer is a high-capacity, oral potassium binder which, if approved, would be the first new therapeutic to treat hyperkalemia in more than 50 years. Relypsa’s NDA is supported by eight clinical trials including a long-term treatment trial that evaluated safety and efficacy for up to one year.

The NDA for Belbuca (buprenorphine HC1) is seeking an indication for management of pain severe enough to require daily long-term opioid treatment and where alternative options are inadequate. Belbuca is a Schedule 3 drug, meaning it has lower abuse potential than most opioids.

Spectrum, which gained the rights to Evomela (melphalan hydrochloride) from Ligand, submitted the NDA for myeloablative conditioning in multiple myeloma patients undergoing autologous stem cell transplantation.

Merrimack’s MM-398 (nanoliposomal irinotecan injection) is up for consideration to treat pancreatic cancer in patients previously treated with gemcitabine-based therapy. The drug received priority review status from the FDA in June following an international Phase 3 trial. — Jonathon Shacat