Your source for the latest industry trends and drug information news.
Volume 7 | Issue 7
April 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On February 28, 2025, the U.S. Food and Drug Administration (FDA) approved the expanded use of Soliris® (eculizumab) for pediatric patients aged six years and older with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. Generalized myasthenia gravis is a rare autoimmune disorder that leads to poor communication between the muscles and nerves, resulting in muscle weakness and quicker muscle fatigue. This approval makes Soliris® the first and only treatment available for pediatric patients with gMG, a significant milestone in treating these patients. Soliris® has been available since 2007 with previous approvals for treating several rare blood and central nervous system disorders and gained approval for use in adult gMG with AChR antibodies in 2017.
Based on the clinical study of 11 pediatric patients aged 12 to 17 years, Soliris® demonstrated that adverse reactions were consistent with those observed in adults. Efficacy has already been established through clinical trials in adults. Soliris® is administered via intravenous infusion over 35 minutes for adults and 1 to 4 hours for pediatric patients. It is contraindicated for patients with unresolved serious Neisseria meningitidis infection. Soliris® is only available through a restricted Risk Evaluation and Mitigation Strategy (REMS) program due to the risk of meningococcal infections, requiring patients to be vaccinated against meningococcal disease at least two weeks prior to initiating treatment.
On March 13, 2025, Dr. Reddy’s Laboratories issued a nationwide recall of one batch of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL, due to mislabeling of the infusion bag. The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap correctly identifies the product. Patients who administered the mislabeled product would likely be exposed to twice the intended dose, increasing the risk of severe side effects, including hypersensitivity reactions, liver damage, blood cell toxicity, drowsiness, fatigue, dizziness, coordination issues, agitation, aggression, reduced consciousness, respiratory depression, and even coma. Patients receiving high doses of levetiracetam by rapid intravenous infusion for the treatment of status epilepticus would be most at risk for severe adverse events.
The lot number of the affected products is A1540076, with an expiration date of 8/26. The single-dose infusion bags have an aluminum overwrap, and there are 10 single-dose bags packaged in a carton. Dr. Reddy’s Laboratories, Inc is notifying its distributors and customers to arrange for the return of any recalled product. Consumers with recalled products should stop use and quarantine the products for return. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program. To date, Dr. Reddy’s has not received any reports of adverse events related to this recall.
On March 14, 2025, the Centers for Medicare & Medicaid Services (CMS) announced that 15 selected drug manufacturers have agreed to participate in the second cycle of the Medicare drug price negotiations. The Medicare Drug Price Negotiation Program is part of the Inflation Reduction Act. It aims to reduce the out-of-pocket cost of beneficiaries and overall Medicare spending.
The second cycle targets widely used high-cost drugs without available generic or biosimilar alternatives. The latest 15 drugs selected for negotiation include treatments for respiratory diseases, diabetes, neurological disorders, and cancer. The full list includes:
CMS will invite each company to a meeting and organize 15, patient-focused roundtable discussions. Negotiations with the participating drug companies for these 15 drugs will take place in 2025, with the agreed-upon prices taking effect in 2027.
New Drug: Omlyclo® (omalizumab-igec)
Subcutaneous (under the skin) injection, approved as biosimilar to Xolair® (omalizumab) for the treatment of moderate to severe persistent asthma in adults and pediatric patients 6 years and older, as well as chronic rhinosinusitis with nasal polyps in adult patients.
Xarelto® (rivaroxaban)
Indication: For the prevention or treatment of blood clots, such as those associated with deep vein thrombosis, pulmonary embolism and stroke.
Dosage Form/Strength: 2.5mg tablets
Average Wholesale Price (AWP): Generic = $615 | Brand = $718
