Imkeldi Approved for Several Types of Cancer
Shorla received approval from the US Food and Drug Administration (FDA) on Nov. 22, 2024, for Imkeldi® (imatinib) oral solution 80mg/mL. At varying doses, it is indicated for use in treating a wide range of cancers, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), gastrointestinal stromal tumors (GIST), and myelodysplastic/myeloproliferative diseases (MDS/MPD). Imatinib, the active ingredient in Imkeldi, is also found in Novartis’ Gleevec®/generics. Imkeldi is a strawberry-flavored oral solution that can be stored at room temperature. Pricing and availability have not yet been disclosed. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. Full prescribing information for Imkeldi can be found here.
New Landiolol Formulation Approved
On Nov. 22, 2024, AOP Orphan Pharmaceuticals received FDA approval for Rapiblyk™ (landiolol) for the short-term reduction of ventricular rate in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter. Landiolol is an ultra-short-acting cardioselective, beta-1 adrenoceptor blocker that reduces heart rate with a minimal effect over cardiac contractility therefore minimally reducing blood pressure. This will be given in the hospital emergency, critical care, and operating room settings as an intravenous (IV) infusion titrated according to ventricular rate. It is not intended for chronic cardiac arrhythmias. No information on pricing and launch is available yet. It will be excluded at launch on the Express Scripts National Preferred Formulary (NPF) until our formulary development process is complete. For full prescribing information, please click here.
Updated DrugWatch Document Available
The Emerging Therapeutics department has updated DrugWatch, a document that highlights near-term pipeline drugs as well as potential new generic opportunities. The DrugWatch document is attached.
Additional Newsflash Sent This Week
- Attruby Approved for Transthyretin-Mediated Amyloidosis Cardiomyopathy – Monday, Nov. 25, 2024