Your source for the latest industry trends and drug information news.
Volume 5 | Issue 20
November 15, 2023
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate
On October 31, 2023, the U.S. Food and Drug Administration (FDA) announced its approval of Wezlana™ (ustekinumab-auub) for the treatment of various autoimmune diseases including Crohn’s Disease and ulcerative colitis in adult patients as well as plaque psoriasis and active psoriatic arthritis in patients 6 years and older.
Wezlana™ is a biosimilar to Stelara® (ustekinumab), one of the leading biologic products available. As a biosimilar, Wezlana™ has no meaningful clinical differences from Stelara®. Wezlana™ was granted interchangeable status, meaning it can be substituted for Stelara® without consulting the prescriber of the medication. This affords access to a treatment option that has the same safety and efficacy as Stelara® but likely at a reduced cost. Like most biologics, patients are advised of the increased risk for infections, fatigue, nausea, fever, diarrhea and injection site reaction. Wezlana™ is expected to be available at the beginning of 2025.
The FDA has announced recalls of various nonprescription eye drops and products from LEADER™ and Rugby® Laboratories due to potential contamination and an increased risk of eye infections. Both brands are supplied by Velocity Pharma, LLC and distributed by Cardinal Health Inc and Harvard Drug Group, LLC, respectively. The recalled LEADER™ products include various strengths and lots of over-the-counter items named Eye Irritation Relief, Dry Eye Relief and Lubricant Eye Drops. There have been 3 reports of adverse events with these products to date. Recalled Rugby® products include Polyvinyl Alcohol 1.4% Lubricating Eye Drops and Lubricating Tears Eye Drops. There have been 3 adverse events reported with these products, including burning eyes, blurred vision and vision loss. Cardinal Health and Harvard Drug Group are notifying impacted parties of this recall. Consumers are advised to discontinue use and contact their health care provider if they experience signs or symptoms of eye infection after using these products. Adverse reactions should be reported to the FDA’s MedWatch Adverse Event Reporting program.
Glucagon-like peptide-1 receptor agonists (GLP-1 agonists) is a class of antidiabetic medications that have become increasingly popular in the treatment of obesity. Treatment with GLP-1 drugs has been shown to improve glucose control and reduce hemoglobin A1C in individuals with diabetes. These medications also slow digestion, provide cardiovascular benefits and promote weight loss.
The first drug approved in this class was Byetta™ in 2005 which is dosed twice daily, every day. As products dosed once weekly became available and research demonstrated weight loss and cardiovascular benefits, competitors such as as Ozempic®, Trulicity®, Wegovy®, Saxenda® and Mounjaro™ have gained attention, with a notable increase in demand in recent years. Common side effects reported with this drug class include constipation, bloating and indigestion. Typically, higher doses result in the greatest glucose control and weight loss but may also lead to a more notable side-effect experience. As a result, patients are started on a low dose and are slowly titrated up to the highest available dose they can tolerate. Patients are advised to follow their prescribed dosing schedule and check in with their provider with any questions or concerns.
With growing popularity, several safety and availability concerns have arisen regarding the GLP-1 drugs. In September 2023, the FDA updated Ozempic®’s label to include a warning of intestinal blockage, known as ileus. This warning already existed on the labels for Wegovy® and Mounjaro™. Ileus is a rare but potentially serious side effect. To date, there have been 33 reported cases of ileus and 2 deaths thought to be caused by the use of a GLP-1 drug. Due to the risk of developing ileus, it is important for a patient’s medical history to be reviewed prior to initiation of a GLP-1 drug to determine if the potential benefits of a GLP-1 agonist outweigh the associated risks.
As newer GLP-1 products have seen a rise in off-label utilization for weight loss without type-2 diabetes, there has been a recent increase in demand and industry-wide shortages, reducing access for some patients with diabetes. This can create a barrier to medication adherence for these patients and interfere with their dosing escalation schedule. Others have also expressed a reluctance to begin a GLP-1 medication because they do not want to be affected by these shortages. Diabetic patients should be informed that alternative GLP-1 drug options are available should a patient choose to switch to a different medication or if their current medication is not available. Manufacturers have taken note of this and are working to increase supplies available to meet demand. Recently, on November 2, 2023, Eli Lilly announced their expansion to increase Mounjaro™ supply and availability. Inventory at wholesalers in the United States has improved, and all six strengths are currently available. Mounjaro™ is only approved for the treatment of diabetes, but Eli Lilly has just received FDA approval for Zepbound™, a product that contains the same active ingredient and is indicated for weight loss. Eli Lilly recognizes that this additional product and indication will lead to a significant increase in demand and are working to provide a sufficient supply of both medications following this approval.
New Drug: Agamree® (vamorolone)
Oral suspension approved for the treatment of Duchenne muscular dystrophy (DMD), a rare and life-threatening disorder causing progressive muscle dysfunction, in patients 2 years and older [10/26/2023 – ORPHAN DRUG – SANTHERA PHARMA]
New Drug: Rozlytrek™ (entrectinib)
Oral capsules approved for the treatment of adult patients with ROS1-positive metastatic non-small cell lung cancer as well as adult and pediatric patients older than 1 month with solid tumors that are metastatic, have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are progressing despite alternative treatment. [10/20/2023 – GENENTECH]
Livalo® (pitavastatin)
Indication: Treatment of hyperlipidemia in adult patients and heterozygous familial hypercholesterolemia in patients 8 years and older.
Dosage Form/Strength: 1mg, 2mg, 4mg oral tablet
Average Wholesale Price (AWP): Generic = $345 | Brand = $384
