Your source for the latest industry trends and drug information news.
Volume 7 | Issue 1
January 1, 2025
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On December 13, 2024, the U.S. Food and Drug Administration (FDA) approved Crenessity™ (crinecerfont) to be used with glucocorticoids to control androgens in adults and pediatric patients 4 years and older with classic congenital adrenal hyperplasia (CAH). CAH is a rare genetic condition affecting the adrenal gland, which produces hormones such as cortisol and androgens. The end result of this genetic condition is that patients with classic CAH do not produce cortisol and produce too many androgens, requiring treatment with high doses of a type of steroid called glucocorticoids. Unfortunately, long-term use with high doses of glucocorticoids can cause side effects such as obesity, high blood pressure and reduced bone density. Crenessity™ is the first and only treatment for classic CAH that directly reduces adrenal androgen production, allowing for glucocorticoid dose reduction.
The approval was based on two randomized, double-blind, placebo-controlled trials in 182 adults and 103 children with classic CAH. In both study trials, the participants who received Crenessity™ experienced reduced adrenal androgen production, compared to an average increase from baseline in the placebo group. The most common side effects of Crenessity™ in adults include fatigue, dizziness and joint pain. For pediatric patients, the most common side effects are headache, abdominal pain and fatigue.
On December 13, 2024, Motivate Me Ashley, LLC issued a recall of the following VidaSlim brand products (Original Root, Root Plus, and Root Capsules): VidaSlim 90-day, VidaSlim 30-day, VidaSlim 7-day Sample Size, and VidaSlim Hot Body Brew. These products were advertised to help promote weight loss, and this recall was initiated due to the confirmed presence of yellow oleander in samples tested. Yellow oleander is poisonous, and its consumption can negatively impact neurological, gastrointestinal and cardiovascular health or even be fatal. Symptoms range in severity but may include nausea, vomiting, dizziness, diarrhea, abdominal pain, arrhythmias and more.
The affected products were sold directly to consumers as well as through distributors and have expiration dates between December 2024 and December 2025. 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 these products. To date, VidaSlim has not received reports of illnesses related to this recall.
On December 10, 2024, the FDA submitted a proposal that could lower the amount of nicotine allowed in tobacco products. The proposal was submitted to the Office of Management and Budget. By setting a limit on nicotine levels in tobacco, it can reduce the addictiveness of cigarettes and certain tobacco products, potentially prompting people to quit smoking. According to the Centers for Disease Control and Prevention (CDC), more than 16 million Americans are living with a smoking-related disease and approximately 28.3 million were considered current smokers as of 2021. Reducing the nicotine content in cigarettes has been shown to make people smoke less and alleviate withdrawal. The FDA estimates that reducing nicotine levels would prevent more than 33 million people from becoming regular smokers, help about 5 million additional smokers to quit within a year, and significantly improve public health.
New Drug: Unloxcyt® (cosibelimab-ipdl)
Intravenous injection approved for the treatment of a type of skin cancer, metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC), in adults who are not candidates for curative surgery or radiation. [12/13/24 – Checkpoint Therapeutics Inc]
Ozobax® (baclofen)
Indication: For the treatment of spasticity resulting from multiple sclerosis.
Dosage Form/Strength: 5mg/5mL oral solution
Average Wholesale Price (AWP): Generic = $815 | Brand = $995
