Your source for the latest industry trends and drug information news.
Volume 6 | Issue 24
December 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On December 4, 2024, the U.S. Food and Drug Administration (FDA) approved Bizengri® (zenocutuzumab-zbco), a targeted therapy indicated for the treatment of adult patients with neuregulin 1 (NRG1) gene fusion positive non-small cell lung cancer (NSCLC) or pancreatic adenocarcinoma whose disease has progressed despite prior therapy. NSCLC is the most common type of lung cancer; it occurs when abnormal cells form and multiply in the lung tissue.Pancreatic adenocarcinoma originates in the cell lining the pancreas and is the most common type of pancreatic cancer. Bizengri® is an intravenous infusion that is given every two weeks until the disease progresses or unacceptable side effects occur.
The approval was based on the results of the eNRGy study. The trial enrolled 64 adults with advanced or metastatic NRG1 fusion-positive NSCLC and 30 adults with advanced or metastatic NRG1 fusion-positive pancreatic adenocarcinoma who had disease progression following standard of care treatment. Response rates for patients with NSCLC and pancreatic adenocarcinoma were 33% and 40%, respectively. Side effects of the medication include diarrhea, musculoskeletal pain, fatigue, nausea and infusion-related reactions. A Boxed Warning has been included in the prescribing information for Bizengri®, indicating potential risks of embryo-fetal toxicity, so use is generally not recommended for patients who are pregnant or planning to become pregnant.
On November 21, 2024, MXBBB announced a voluntary recall of one lot of the dietary supplement Umary hyaluronic acid 850mg caplets. The product is being recalled due to the presence of diclofenac and omeprazole. Diclofenac is a non-steroidal anti-inflammatory drug that may increase the risk of gastrointestinal damage and cardiovascular events, such as heart attack and stroke. Omeprazole is a proton pump inhibitor (PPI) used to treat stomach acid-related disorders. PPI medicines may cause serious skin reactions, abdominal pain, diarrhea, nausea and headaches.
The impacted products were distributed by Amazon and are labeled with lot number 24183 and expiration date: 07/01/28. MXBBB is notifying its customers through Amazon and arranging for the return of all recalled products. Consumers with recalled products should immediately stop using them and contact their health care provider if they have experienced any problems that may be related to use of this drug. To date, MXBBB has not received any reports of adverse events related to this recall.
Sotagliflozin (Inpefa™) is a prescription medication that lowers the risk of cardiovascular death, heart failure-related hospitalizations and urgent heart failure visits in adults with heart failure or type 2 diabetes, chronic kidney disease (CKD) and other cardiovascular risk factors. A study found sotagliflozin can help manage anemia in patients with type 2 diabetes and CKD. Individuals with CKD are at risk for developing anemia because impaired kidneys produce less erythropoietin, a hormone that stimulates the bone marrow to produce red blood cells. In this study, anemia was defined as baseline hemoglobin levels < 13mg/dL in men and < 12mg/dL in women. Researchers conducted an analysis of pooled data from two clinical trials comparing the effect of sotagliflozin (200mg and 400mg) with that of placebo on hemoglobin levels in patients with type 2 diabetes and CKD stages III-IV who did or did not have anemia. Compared with placebo, treatment with sotagliflozin increased mean hemoglobin levels by 0.27 g/dL in participants with anemia and 0.50 g/dL in those without. Sotagliflozin significantly increased the likelihood of resolution of anemia over 26 weeks in participants with the condition at baseline.
New Drug: Yesintek™ (ustekinumab-kfce)
Subcutaneous (under the skin) or intravenous injection approved as a biosimilar to Stelara® for the treatment of multiple inflammatory autoimmune disorders, including plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease. [11/29/2024 – BIOCON BIOLOGICS INC]
Clomid® (clomiphene citrate)
Indication: For the treatment of infertility.
Dosage Form/Strength: 50mg tablets
Average Wholesale Price (AWP): Generic = $47 | Brand = $47
