Your source for the latest industry trends and drug information news.
Volume 6 | Issue 14
July 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On July 2, 2024, the U.S. Food and Drug Administration (FDA) approved Kisunla™ (donamemab-azbt), a monoclonal antibody, for the treatment of adults with Alzheimer’s disease. Alzheimer’s disease is a brain disorder characterized by progressive loss of memory and cognitive function. The cause of the disease is not completely known, and current treatment focuses on slowing the progression of cognitive impairment. Kisunla™ acts by targeting and destroying amyloid plaques in the brain, which begin to accumulate prior to the onset of dementia symptoms and potentially disrupt brain signaling. It is only intended for use in patients in the early stages of Alzheimer’s disease who have amyloid plaque present, as confirmed by brain imaging. In a clinical trial of patients with mild cognitive impairment or mild dementia stage, Kisunla™ was found to significantly slow the progression of Alzheimer’s-related symptoms compared to placebo. In addition, participants who received Kisunla™ were found to have amyloid plaques reduced by an average of 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study. Kisunla™ is an intravenous infusion that is administered every 4 weeks by a health care professional. During treatment, routine brain scans need to be performed to monitor for resolution of plaques as well as the development of swelling or bleeding in the brain.
On June 24, 2024, Glenmark Pharmaceuticals announced the recall of 114 batches of potassium chloride 10 mEq extended-release capsules due to failed dissolution. Potassium chloride capsules are used to treat patients with low potassium levels. Use of the affected products may elevate potassium levels dangerously high and result in irregular heartbeat and potentially lead to cardiac arrest. Patients who require chronic potassium supplementation, particularly those with conditions such as hypertension on diuretics (water pills), heart failure or renal dysfunction, are at a higher risk of developing high potassium levels (hyperkalemia).
Glenmark’s potassium chloride 10 mEq ER capsules are packaged in bottles of 100-count (NDC 68462-0357-01) and 500-count (NDC 68462-0357-05). A list of the recalled lot numbers can be found here. To date, Glenmark Pharmaceuticals has not received any reports of hyperkalemia or serious adverse events related to this recall. Consumers with the affected batches should consult with their physician or health care provider before they stop using the product, or if they have experienced any problems that may be related to this recall. Adverse effects should also be reported to the FDA’s MedWatch Adverse Event Reporting program.
On June 27, 2024, the U.S. Food and Drug Administration (FDA) announced the marketing authorization for the first hepatitis C virus (HCV) test, Xpert HCV test and GeneXpert Xpress System made by the company Cepheid. This is a rapid, point-of-care test which can detect HCV RNA and deliver results in about an hour using a blood sample from the fingertip. The rapid testing of HCV allows for a test-and-treat approach where an individual can be tested for HCV and potentially receive treatment during the same visit if tested positive. The test can be performed in facilities with a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, including doctor’s offices, urgent care clinics, emergency departments, syringe service programs, correctional facilities and certain substance use disorder treatment facilities.
Hepatitis C is a liver infection characterized by symptoms like fatigue, nausea, loss of appetite and yellowing of the eyes and skin. According to the CDC, it is estimated that more than 2.4 million people in the United States have hepatitis C. One third of people with hepatitis C are not aware that they are infected with HCV. The availability of HCV test is expected to diagnose and treat more people with hepatitis C. Adults who are at risk of hepatitis C or adults with signs and symptoms of hepatitis C will be candidates for testing. The marketing authorization was granted to Cepheid under the FDA’s De Novo premarket review pathway, which is for low to moderate-risk devices of a new type.
New Drug: Approvals
New Drug: Sofdra™ (sofpironium)
Topical gel indicated for the treatment of excessive under arm sweating without an underlying cause (primary axillary hyperhidrosis) in adults and pediatric patients 9 years of age and older. [6/18/2024 - Botanix]
New Drug: Pyzchiva® (ustekinumab-ttwe)
Subcutaneous injection approved as an interchangeable biosimilar to Stelara® (ustekinumab) for the treatment of multiple inflammatory autoimmune disorders, including psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis in certain patients. This medication is scheduled to launch in February 2025. [6/28/2024 - Samsung Bioepis]
Victoza® (liraglutide)
Indication: Subcutaneous GLP-1 injection approved for adults with type 2 diabetes mellitus used to improve blood sugar control and reduce the risk of major cardiovascular events.
Dosage Form/Strength: 18 mg/3 mL injection
Average Wholesale Price (AWP): Generic = $930 | Brand = $1,220
