Your source for the latest industry trends and drug information news.
Volume 6 | Issue 7
April 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate
On March 14, 2024, the U.S. Food and Drug Administration (FDA) approved Rezdiffra™ (resmetirom), the first treatment option for patients with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis in adults. NASH is the result of progressive inflammation and fat accumulation in the liver unrelated to alcohol consumption. Inflammation of the liver can produce scarring in the organ, increasing the risk of cirrhosis and permanent damage. Approximately 6-8 million people in the U.S. have NASH with moderate to advanced liver scarring. Rezdiffra™ works by stimulating thyroid hormone receptors in the liver to reduce the buildup of fat in the organ. In a clinical trial comparing the addition of Rezdiffra™ or placebo to diet and exercise, a greater proportion of the Rezdiffra™ group achieved NASH resolution or improvement in liver scarring. Common side effects such as diarrhea and nausea were observed during the clinical trial. Rezdiffra™ should be avoided in patients who have worsening liver function with cirrhosis, and the drug should be stopped if patients develop signs or symptoms of worsening liver function during treatment. Approval was granted via the FDA’s accelerated approval pathway, and it received Breakthrough Therapy, Fast Track and Priority Review designations. .
On March 12, 2024, Par Pharmaceutical issued a voluntary recall of one lot of Treprostinil Injection 20mg/20mL (1mg/mL) vials, a medication used to treat pulmonary hypertension, due to the potential presence of silicone particulates in the product solution. Administration of this solution may result in local irritation or swelling in response to the particulates. If the particulates reach the blood vessels, they can cause a block in the vessels of the heart, lungs or brain which can lead to stroke and even death. The recalled product is associated with multidose vials with Lot#57014 and expiration date of April 2024, and it was distributed to wholesalers and hospitals nationwide. The company is providing written notification to hospitals and wholesalers, instructing them to withdraw any stock of the affected lot from shelves immediately, to return any of these vials and to notify any recipients of the affected product. There have been no adverse events related to this recall to date, but patients should contact their health care provider if any problems arise from use of this product. Adverse effects should also be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.
On March 5, 2024, the FDA cleared the first continuous glucose monitor (CGM) to be marketed for over the counter (OTC) use in adults. The Dexcom Stelo Glucose Biosensor System is a wearable sensor that pairs with an application on the user’s smartphone, continuously measures blood glucose levels and displays these values every 15 minutes throughout the day. The sensor is worn on the back of the upper arm, and it may be worn for up to 15 days before needing replacement. Previously approved CGMs require a prescription from a health care provider and are intended for use in patients with diabetes who are treated with insulin therapy to ensure proper insulin dosing. The clearance of an OTC device increases access to a CGM for adults with diabetes who do not use insulin or those without diabetes who want to gain better understanding of how diet and exercise may be impacting their blood sugar levels. Individuals with frequent low blood sugar are not recommended to use this device, as it is not configured to alert users when they may be at a dangerously low level. Most side effects were localized to the upper arm and included infection, skin irritation, pain and discomfort. Clinical study results showed that this device performed similarly to previously approved CGMs that require a prescription. However, users should consult with their health care provider before making any medical decisions based on the output from the device. Stelo is expected to be available online this summer.
New Indication: Wegovy® (semaglutide)
Subcutaneous injection approved to reduce the risk of heart attack, stroke and cardiovascular death in overweight or obese adults with previously established cardiovascular disease. [03/08/2024 – NOVO NORDISK]
Rectiv® (nitroglycerin)
Indication: Treatment of moderate to severe pain associated with chronic anal fissure
Dosage Form/Strength: 0.4% Ointment
Average Wholesale Price (AWP): Generic = $692 | Brand = $769
Thiola® (tiopronin)
Indication: Prevention of kidney stone formation in adult and pediatric patients with severe cystinuria, a rare genetic disorder in which the amino acid cystine accumulates in the urine and forms stones
Dosage Form/Strength: 100mg, 300mg oral delayed-release tablets
Average Wholesale Price (AWP): Generic = $9,140 | Brand = $9,140
