Ingrezza Sprinkles for Huntington’s, Tivdak for Cervical Cancer, Xolremdi for WHIM, Esprit Stent for CLTI-BTK

New FDA Approvals

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• The FDA has approved valbenazine (INGREZZA® SPRINKLE) capsules for adults with tardive dyskinesia and chorea associated with Huntington's disease.
• This new oral granules formulation provides an alternative for those with swallowing difficulties, maintaining the same dosage strengths as the original capsule form.
• Valbenazine is a selective vesicular monoamine transporter 2 (VMAT2) inhibitor designed to reduce uncontrollable movements by inhibiting dopamine release.

Tivdak for Cervical Cancer:

• Tisotumab vedotin-tftv (TIVDAK) has been approved for recurrent or metastatic cervical cancer after chemotherapy failure.
• This approval was based on results from a Phase 3 trial showing a significant overall survival benefit compared to chemotherapy.
• The approval highlights a significant advancement in treating this aggressive form of cancer, granted to Pfizer and Genmab A/S.

Xolremdi for WHIM:

• Mavorixafor (Xolremdi) has been approved for WHIM syndrome in patients 12 years and older to increase circulating neutrophils and lymphocytes.
• WHIM syndrome is a rare genetic disorder impairing immune function, and mavorixafor significantly improves cell counts and reduces infection risk.
• Approval was based on positive results from a double-blind trial and granted to X4 Pharmaceuticals.

Esprit Stent for CLTI-BTK:

• The FDA has approved the Esprit™ BTK Everolimus Eluting Resorbable Scaffold System for chronic limb-threatening ischemia below-the-knee.
• This is the first approval of its kind in the U.S., offering an alternative to traditional balloon angioplasty.
• The approval was based on positive outcomes from the LIFE-BTK trial, showing significant disease progression reduction compared to standard care, granted to Abbott Laboratories.