.png)
Capital Rx
Highlights
- Three key new drug approvals, including Iqirvo® for PBC, an autoimmune disease
- Eight (8) notable expanded indications
- Four (4) biosimilar approvals (alternatives to Eylea® and Soliris®) and one generic launch
- Capital Rx's Updated Drug Recall Report: CLICK HERE to review
Capital Rx's Clinical Team closely monitors the drug landscape to provide our clients with timely information on newly FDA-approved medications, as well as products in the pipeline. Read on to review our June 2024 Monthly Drug Update!
Key New Drug Approvals
Onyda™ (clonidine) oral suspension
Approval Date: 05/24/2024 - CLICK HERE for the press release
Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age or older
Cost*: TBD
Key Considerations:
- New clonidine extended-release dosage form
- Once daily dosing before bedtime
- First and only non-stimulant liquid ADHD medication
Iqirvo® (elafibranor) tablet
Approval Date: 06/06/2024 - CLICK HERE for the press release
Indication: Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults
Cost*: $11,500 per month
Key Considerations:
- Received priority review
- Orphan drug designation
- Not recommended in patients who have or develop decompensated cirrhosis
Sofdra™ (sofpironium) topical gel
Approval Date: 06/18/2024 - CLICK HERE for the press release
Indication: Treatment of primary axillary hyperhidrosis in patients 9 year of age and older
Cost*: TBD
Key Considerations:
- Once daily application at bedtime
- Dispensed as a gel pump
Notable Expanded Indications
Retevmo® (selpercatinib) – expanded to treat advanced or metastatic medullary thyroid cancer (MTC) with RET mutation in patients 2 year of age and older; expanded to treat advanced or metastatic thyroid cancer with a RET gene fusion in patients 2 years of age and older
Motpoly XR™ (lacosamide) – expanded to treat primary generalized tonic-clonic seizures in patients weighing at least 50 kg as adjunctive therapy
Xigduo® XR (dapagliflozin/metformin) – expanded to improve glycemic control in patients 10 years of age and older with type 2 diabetes
Farxiga® (dapagliflozin) – expanded to improve glycemic control in patients 10 years of age and older with type 2 diabetes
Augtyro™ (repotrectinib) – expanded to treat solid tumors that have a neurotrophic tyrosine receptor kinase (NRTK) gene fusion in patients 12 years and older
Wakix® (pitolisant) – expanded to treat excessive day-time sleepiness in patients 6 years of age and older
Krazati® (adagrasib) – expanded to treat colorectal cancer in combination with cetuximab
Klysri® (tirbanibulin) – expanded to include the treatment of actinic keratosis on areas of the face or scalp up to 100cm2
Biosimilar Approvals
Yesafili™ (aflibercept-jbvf) intravitreal injection
Approval Date: 05/20/2024 - CLICK HERE for the press release
Indication: Treatment of Neovascular (wet) Age-Related Macular Degeneration (AMD), treatment of Macular Edema following Retinal Vein Occlusion (RVO), treatment of Diabetic Macular Edema (DME), treatment of Diabetic Retinopathy (DR)
Additional Information:
- Interchangeable biosimilar to Eylea®
Opuviz™ (aflibercept-ysvy) intravitreal injection
Approval Date: 05/20/2024 - CLICK HERE for the press release
Indication: Treatment of Neovascular (wet) Age-Related Macular Degeneration (AMD), treatment of Macular Edema following Retinal Vein Occlusion (RVO), treatment of Diabetic Macular Edema (DME), treatment of Diabetic Retinopathy (DR)
Additional Information:
- Interchangeable biosimilar to Eylea®
Bkemv™ (eculizumab-aeeb) IV
Approval Date: 05/28/2024 - CLICK HERE for the press release
Indication: Treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; treatment of atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy
Additional Information:
- First interchangeable biosimilar to Soliris®
- Black box warning for infections caused by Neisseria meningitidis
Ahzantive® (Aflibercept) intravitreal injection
Approval Date: 06/28/2024 - CLICK HERE for the press release
Indication: Treatment of patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO)
Additional Information:
- Biosimilar to Eylea®
Generic Launches
Emflaza® (deflazacort 22.75 mg/mL) oral suspension
Contact Us if you'd like to learn more about Capital Rx's full-service pharmacy benefit management (PBM) solutions and clinical programs.
--------
* Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support