Your source for the latest industry trends and drug information news.
Volume 7 | Issue 6
March 15, 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 Genentech’s TNKase® (tenecteplase) for the treatment of acute ischemic stroke in adult patients. TKNase® was originally approved by the FDA in 2000 for the treatment of adults with a type of heart attack known as an acute ST-elevation myocardial infarction (STEMI) and now becomes the second medication to be approved for the treatment of stroke, following Activase® (alteplase). Strokes occur in more than 795,000 adults each year and are the leading cause of long-term disability as well as the fifth-leading cause of death. An ischemic stroke occurs when a blood clot blocks a blood vessel in a person’s brain. This blockage prevents oxygen from reaching the affected part of the brain and can rapidly result in brain damage, making immediate medical care essential. TKNase® works by enhancing the production of plasmin, an enzyme that dissolves blood clots.
In the randomized controlled trial, TNKase® demonstrated comparable safety and efficacy to Activase® for the treatment of acute ischemic stroke within 4.5 hours of symptom onset. TNKase® only takes 5 seconds to administer, allowing it to be given much faster than Activase® which must be administered as an initial dose followed by a 60-minute infusion. Common adverse reactions include bleeding and hypersensitivity. Genentech will introduce a new 25 mg vial, the recommended dose for stroke, in the second quarter of 2025.
On February 20, 2025, One Source Nutrition, Inc. announced a voluntary recall of all lots of Vitality capsules. The over the counter (OTC) products were found to contain sildenafil and tadalafil, which are active ingredients used in FDA-approved prescription products for the treatment of male erectile dysfunction. Consumption of these products may interact with nitrate drugs (such as isosorbide mononitrate and nitroglycerin) used to treat cardiac conditions, leading to unintended side effects such as a significant drop in blood pressure.
Vitality capsules are marketed as a dietary supplement used as a male enhancement product. They are not marked with lot numbers or expiration dates. The products are packaged as a single pill in an orange and gray package with blue writing. One Source Nutrition is notifying distributors and consumers by email and arranging the return of the recalled products. Consumers with recalled products should return them to their place of purchase or discard the product and contact their health care provider if any problems develop relating to this product. Adverse events should be reported to the FDA's MedWatch Adverse Event Reporting program. To date, One Source Nutrition has not received any reports of adverse events related to this recall.
On February 24, 2025, the FDA announced the removal of clozapine from the Risk Evaluation and Mitigation Strategy (REMS) program to reduce health care system burden and improve drug access. REMS is an FDA-required safety program for certain high-risk medications to ensure drug benefits outweigh risks.
Clozapine is an antipsychotic medication used to treat schizophrenia in patients who don’t respond to other antipsychotic treatments. However, an undesired side effect of Clozapine is a potential reduction in the number of white blood cells which would increase the risk of serious infection. The REMS program required the submission of absolute neutrophil count (ANC) blood test results to monitor a reduction in certain types of white blood cells before clozapine could be dispensed from the pharmacy. While frequent blood tests are still recommended, the FDA advisory committee believes that eliminating clozapine from the REMS program will help reduce the burden on the health care delivery system and improve access to clozapine for patients with treatment-resistant schizophrenia or with recurrent suicidal behavior associated with schizophrenia. The risk of severe neutropenia, in which ANC drops below 500 cells/uL, will remain listed within the boxed warning on all clozapine products.
New Drug: Romvimza™ (vimseltinib)
Oral capsules approved for the treatment of symptomatic tenosynovial giant cell tumor, a rare benign tumor that causes joint swelling and pain, in adults when surgery could worsen movement or lead to serious complications. [2/14/2025 - Ono Pharmaceutical Co]
New Drug: Stoboclo® (denosumab-bmwo) as a biosimilar to Prolia®
A biosimilar to Prolia®(denosumab) approved for the treatment of osteoporosis in men and postmenopausal women at high-risk for fractures and as prevention for patients undergoing other certain treatments. [2/28/2025 - Celltrion]
Ridaura® (auranofin)
Indication: For the treatment of active rheumatoid arthritis in adults who have failed or cannot tolerate other rheumatoid arthritis therapies.
Dosage Form/Strength: 3mg oral capsules
Average Wholesale Price (AWP): Generic = $1,860 | Brand = $1,879
