Your source for the latest industry trends and drug information news.
Volume 6 | Issue 20
October 15, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On September 26, 2024, the U.S. Food and Drug Administration (FDA) approved Cobenfy™ (xanomeline and trospium chloride) capsules for the treatment of adults with schizophrenia. Schizophrenia is a severe chronic mental illness that can cause psychotic symptoms, including delusions, hallucinations and disorganized thoughts. It is also associated with cognitive problems, difficulty with social interaction and lack of motivation. Cobenfy™ is the first oral antipsychotic drug approved to treat schizophrenia that targets cholinergic receptors as opposed to dopamine receptors in the brain. Cobenfy™ contains two ingredients. The first ingredient, xanomeline, treats the symptoms of schizophrenia. The second ingredient, trospium chloride, minimizes the risk of potential side effects from xanomeline.
The approval of Cobenfy™ for the treatment of schizophrenia was based on the results of two clinical studies with identical designs. The effectiveness of Cobenfy™ was evaluated using a rating scale that measures the severity of 30 symptoms of schizophrenia. In both studies, the participants who received Cobenfy™ experienced a meaningful reduction in symptom severity from baseline to week 5 compared to the placebo group. Cobenfy™ should not be prescribed to patients with urinary retention, moderate or severe kidney or liver disease, gastric retention or untreated narrow-angle glaucoma. The most common side effects are nausea, indigestion, constipation, vomiting, elevated blood pressure and heart rate, abdominal pain, diarrhea and dizziness. Cobenfy™ is expected to be available through pharmacies in late October 2024.
On September 20, 2024, Gilead Sciences, Inc. issued a voluntary recall of one lot of Veklury® (remdesivir) 100 mg vials for injection. The recall was initiated due to the confirmed presence of a glass particle in a vial that was initially identified by a customer. Use of the affected product could cause local irritation or swelling in response to the foreign material. The glass particulate could potentially travel through the bloodstream and block blood vessels in the heart, lung or brain, putting a patient at risk for stroke and death.
Veklury® is indicated for the treatment of COVID-19 in adults and pediatric patients. The affected product lot is 47035CFA with an expiration date of November 2025. The vials were distributed to wholesalers and heath care facilities in the United States. Gilead is providing instructions to these entities for returning the affected products. To date, there have been no reports of adverse events related to this recall. Adverse events related to the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
As of October 2, 2024, the FDA determined that the shortage of tirzepatide injection has been resolved. Tirzepatide is a glucagon-like peptide 1 (GLP-1) medication. It is the active ingredient in Mounjaro®, which is approved for the treatment of type 2 diabetes mellitus, and Zepbound®, which is approved for use in weight management. With increased demand, these commercially available tirzepatide products have been in shortage since 2022. The manufacturer recently confirmed that they have increased product availability and manufacturing capacity and are now prepared to meet the present and projected demand. However, there may still be disruptions in local supply as the products move from the manufacturer to distributors and pharmacies. Other GLP-1 medications, such as Ozempic®, Wegovy® and Trulicity®, are still in shortage.
During the shortage of commercially available GLP-1 medications, some compounding pharmacies have been able to legally produce unbranded versions of these drugs that contain the same active ingredients to help meet patient demand. However, the FDA highlights that compounded drugs are not approved by their agency. There are also legal restrictions on making compounded versions of FDA-approved drugs, and compounded drugs must meet conditions to quality for exemptions, namely sections 503A and 503B of the Federal Food, Drug and Cosmetic (FD&C) Act. As shortages resolve, production of compounded versions will likely be discontinued.
New Drug: Miplyffa™ (arimoclomol)
Oral capsules approved, in combination with miglustat, for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adult and pediatric patients 2 years and older. NPC is a rare genetic disorder in which cholesterol and other fats accumulate in body tissues, including the brain. This leads to symptoms such as impaired muscle control and movement, slurred speech and uncontrolled eye movements.
Indication: Topical cream for patients with plaque psoriasis.
Dosage Form/Strength: 0.05% cream
Average Wholesale Price (AWP): Generic = $576 | Brand = $519
