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Volume 6 | Issue 2
January 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate
On January 5, 2024, Ligand Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) approval of Zelsuvmi™ (berdazimer) 10.3% topical gel for the treatment of molluscum contagiosum in patients 1 year and older. Molluscum contagiosum is a viral skin infection that may lead to the development of small lesions on the body, primarily the arms, legs, face, neck, abdomen and genital area. It is highly contagious and affects nearly 6 million Americans each year. The infection can resolve on its own, but it usually takes 6 to 12 months for complete clearance. Until the skin infection has completely cleared, patients are contagious and may spread the infection to others. Children are the most common group to get this infection, and approximately 73% go untreated. Zelsuvmi™ is a novel antiviral treatment that is applied to the lesions once daily. It is the first drug approved for at-home treatment of molluscum contagiosum. In clinical trials, it was well tolerated and effective at reducing lesion counts and severity. More patients treated with Zelsuvmi™ achieved complete clearance of lesions at 12 weeks compared to those treated with placebo. The most reported side effects were burning or stinging at the application site. This gel will provide pediatricians and dermatologists with an appropriate and efficacious treatment option for this highly contagious skin infection.
On December 22, 2023, Insight Pharmaceuticals announced a voluntary recall of one lot of Americaine® 20% Benzocaine Topical Anesthetic Spray. Used topically to relieve pain, itching or irritation of the skin, this spray is packaged in a white aerosol can with a teal cap. The impacted lot code is 1A16420 with an expiration date of 01/25, both of which can be found on the bottom of the can. The affected lot was found to contain a low level of benzene in the propellant used to deliver the medication from the spray can. No other lots were found to contain benzene, which is a carcinogen that may increase the risk of cancer. Consumers with the affected lot are encouraged to immediately stop using the product and discard it. They may receive a full refund by providing an image of the affected product to Insight Pharmaceuticals. There have been no adverse events related to this recall to date, but patients should contact their health care provider if any problems have arisen from use of this product. Adverse effects should also be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
A retrospective observational study was conducted in the United States to evaluate the risk of suicidal ideation in patients treated with semaglutide medications, such as Ozempic® and Wegovy®. Semaglutide is a GLP-1 agonist that is effective in controlling blood sugar levels as well as appetite. Ozempic® is indicated for the treatment of type 2 diabetes, and Wegovy® is indicated for obesity. Since 2010, the FDA has received 265 reports of suicidal thoughts or behavior in patients taking semaglutide or similar medications, with 36 of these resulting in death. Based on this, suicidal ideation has been listed as a potential safety concern worth further investigation for GLP-1 agonists by the FDA.
The researchers reviewed 240,258 patients taking Wegovy® or other weight loss medications and approximately 1.6 million patients taking Ozempic® or other type 2 diabetes medications. During the first 6 months, reports of first-time suicidal ideation were seen in 0.11% of Wegovy® patients versus 0.43% of patients who were taking other prescription weight loss drugs. The risk of first-time suicidal ideation was 73% lower in the Wegovy® group, and the risk of recurrent suicidal thoughts was 56% lower than other weight loss medications. There were no suicide attempts seen in the Wegovy® group, but 14 users of other weight loss drugs reported a suicide attempt. Ozempic®, when compared with other type 2 diabetes medications, showed a similar pattern to Wegovy®. Findings were consistent across sex, age, or ethnicity.
A key limitation to interpreting the findings of this study was the retrospective use of existing data. Researchers could not customize the data collected for specific measures and had to rely on the information provided in electronic health records. This may have led to underreported suicidal ideation as it is likely that not all patients were asked about this during routine clinical visits. Consequentially, this study cannot definitively prove that GLP-1 agonists do not increase the risk of suicidal thoughts. Further research is warranted, using clinical trials designed to collect and analyze specific measures of suicidal thoughts and behaviors in patients prescribed a GLP-1 agonist medication.
New Drug: Filsuvez® (birch triterpenes)
Topical gel approved for the treatment of wounds associated with dystrophic and junctional epidermolysis bullosa, a rare genetic connective tissue disorder, in adult and pediatric patients 6 months and older [12/18/2023 – Amryt Pharma Inc]
New Drug: Wainua™ (eplontersen)
Subcutaneous injection approved for treatment of adult patients with polyneuropathy of hereditary transthyretin-mediated amyloidosis, a debilitating genetic disorder that causes nerve damage and motor disability [12/21/2023 – Ionis Pharma Inc]
*As of this issue, there were no new generics entering the marketplace.
