Your source for the latest industry trends and drug information news.
Volume 7 | Issue 5
March 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On February 3, 2025, Supernus Pharmaceuticals, Inc. announced the U.S. Food and Drug Administration (FDA) approval of Onapgo™ (apomorphine hydrochloride) injection to treat motor fluctuations in adults with advanced Parkinson’s Disease. Onapgo™ is a wearable subcutaneous infusion device that provides a significant reduction in OFF time (periods during the day when symptoms are not well controlled). Most patients with Parkinson’s disease experience worsened motor symptoms as disease progresses. Consistent control of OFF time can improve how patients feel and move throughout the day.
In the phase 3, double-blind, randomized, placebo-controlled study, Onapgo™ demonstrated a significant reduction in daily OFF time at 12 weeks from baseline compared to placebo. Patients in the Onapgo™ group had a 2.6-hour reduction in OFF time while the placebo group had a 0.9-hour reduction. Patients treated with Onapgo™ also reported improvement in their general health. Common adverse reactions include infusion-site reaction, nausea, sleepiness, sudden uncontrolled movements, headache and insomnia. Onapgo™ is expected to be available in the second quarter of 2025.
On February 13, 2025, ICU Medical, Inc. announced a voluntary recall of one lot of potassium chloride injection bags due to dose mislabeling. The bags of potassium chloride injection 20mEq are incorrectly labeled as 10mEq on the overwrap. Potassium chloride injections are indicated for low potassium levels in the blood, often given intravenously in patients who cannot tolerate oral therapy. If administered, patients would receive a higher dose of potassium chloride than intended, potentially resulting in muscle weakness, low blood pressure, altered mental state, dizziness, altered heart rhythm or death from cardiac arrest. There is a higher risk of fatal complications in patients with heart or kidney disease.
The affected product is packaged in 100ml bags labeled with lot number 1023172 and an expiration date of 1/31/2026. ICU Medical has provided written notifications to distributors and direct customers. To date, ICU Medical has not received any reports of illness related to this recall. Any adverse events suspected to be associated with this recall should be reported to the FDA's MedWatch Adverse Event Reporting program.
On February 14, 2025, the FDA approved Penmenvy® (Meningococcal Groups A, B, C, W, and Y Vaccine) for individuals 10 to 25 years old to prevent invasive meningococcal disease (IMD) caused by Neisseria meningitidis (A, B, C, W and Y). IMD is a serious infection caused by bacteria that can lead to inflammation of the membrane surrounding the brain and spinal cord, which progresses rapidly and can result in brain damage, hearing loss and amputation.
Penmenvy® combines components from GSK’s existing vaccines, Bexsero® (Meningococcal Group B) and Menveo® (Meningococcal Groups A, C, Y and W-135), into a single injection. The efficacy and safety of Penmenvy® have been established in two clinical trials that included over 4,800 participants ages10 to 25. The safety data demonstrated that the vaccine has a safety profile consistent with Bexsero® and Menveo®. Common adverse events include pain at injection site, headache, fatigue and nausea.
New Drug: Gomekli™ (mirdametinib)
Oral capsules and oral suspension approved for the treatment of neurofibromatosis type 1 (NF1) in adults and children 2 years and older who develop tumors in the tissues along the nerves that cause symptoms and cannot be completely removed by surgery. [2/11/25 – Springworks Therapeutics Inc]
New Drug: Merilog™ (insulin aspart-szjj)
A rapid acting human insulin analog approved as a biosimilar to Novolog®, indicated to control high blood sugar in adults and children with diabetes mellitus. [2/14/25 – Sanofi-Aventis U.S. LLC]
Entresto® (sacubitril/valsartan)
Indication: For the treatment of heart failure in adults and for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients.
Dosage Form/Strength: 24-26mg, 49-51mg, 97-103 mg oral tablets
Average Wholesale Price (AWP): Generic = $826 | Brand = $846
Namzaric® (memantine/donepezil)
Indication: For the treatment of moderate to severe Alzheimer's disease.
Dosage Form/Strength: 14-10mg, 28-10mg oral tablets
Average Wholesale Price (AWP): Generic = $707 | Brand = $744
