RiVive, Balfaxar, Xdemvy

New FDA Approvals

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Here is information on the latest US FDA approvals, the week of July 24 – July 28, 2023. Just to summarize up front, we have RiVive receiving other the counter approval for opioid overdose; Balfaxar for urgent reversal of warfarin (VKA) therapy; Xdemvy for a common eyelid condition, Demodex blepharitis. PDUFA dates this week: Remestemcel-L for acute GVHD and zuranolone for major depressive disorder and postpartum depression. Here are the highlights:

· RiVive (naloxone hydrochloride nasal spray) has been approved by the FDA for over-the-counter use to treat known or suspected opioid overdose, rapidly reversing opioid effects and restoring normal respiration. This approval marks the second nonprescription naloxone product, the other being Narcan.

· Balfaxar® (prothrombin complex concentrate, human-lans) has received FDA approval for urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy in adult patients requiring urgent surgery or invasive procedures. Balfaxar® replenishes deficient clotting factors caused by warfarin therapy and was supported by the LEX-209 clinical trial, demonstrating hemostatic efficacy and non-inferiority to a comparator, Kcentra®. The medication includes a boxed warning for thromboembolic event risk.

· XdemvyTM (lotilaner ophthalmic solution 0.25%) has been approved by the FDA as the first treatment for Demodex blepharitis, targeting inflammation caused by Demodex mites. Administered as an eye drop, Xdemvy eradicates the mites over six weeks, providing relief for patients with eyelid inflammation and discomfort. The treatment was well-tolerated, with common adverse reactions being eye stinging and burning in about 10% of patients.

· Upcoming PDUFAs

Remestemcel-L, being developed for acute graft versus host disease (aGVHD), has a PDUFA date of August 2. Derived from mesenchymal stromal cells, it may treat this life-threatening complication of bone marrow transplants. Currently, there are no approved treatments for steroid-refractory aGVHD in children under 12, making Remestemcel-L a potential solution.

Zuranolone (SAGE-217) has a PDUFA date of August 5 for major depressive disorder and postpartum depression. This potential treatment, a positive allosteric modulator of GABA-A receptors, aims to rebalance dysregulated neuronal networks to help reset brain function in people with depression.

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