Your source for the latest industry trends and drug information news.
Volume 4 | Issue 23
December 1, 2022
Contributors:
Chief Authors: Rebecca Waite, PharmD, Bonnie Broczkowski, PharmD & Colleen Peehler, PharmD
Contributing Authors: Yi (Eve) Zheng, PharmD/MBA Candidate, Gabrielle Graca, PharmD/MBA Candidate
On November 17, 2022, the U.S. Food and Drug Administration (FDA) approved the first drug that can delay the onset of type 1 diabetes . Tzield (teplizumab-mzwv) is approved for use in adults and children over 8 years with stage 2 (presymptomatic) type 1 diabetes to delay the progression to stage 3 (symptomatic) type 1 diabetes. Type 1 diabetes occurs when a person’s immune system attacks and destroys beta-cells in their pancreas. These beta-cells produce insulin in the body, which regulates blood glucose levels. Without insulin-producing beta-cells, patients experience high blood glucose levels and need to receive insulin injections or wear insulin pumps to control their glucose. These treatments are costly and are necessary for a patient’s survival. Tzield works by binding to and deactivating the immune cells that destroy pancreatic insulin-producing cells, thereby delaying progression to symptomatic disease and the burdens of its treatment. Tzield was shown to be safe and effective in a clinical trial that evaluated 76 patients with stage 2 type 1 diabetes. The patients received a once-daily intravenous infusion for 14 days of either Tzield or a placebo. After 51 months (about 4 and a half years), 45% of the patients receiving Tzield and 72% of the patients receiving placebo were diagnosed with stage 3 type 1 diabetes, showing that Tzield prevented progression better than placebo. The most common side effects reported with Tzield were rash, headache and decreased white blood cell count. Patients receiving Tzield should be monitored for decreased white blood cell counts, hypersensitivity reactions and an overreaction of the immune system in response to the injection known as Cytokine Release Syndrome. For the first 5 days of treatment, patients should be premedicated with a nonsteroidal anti-inflammatory drug or acetaminophen, an antihistamine and/or a medication to prevent nausea and vomiting before giving the infusion. Prior to starting Tzield, patients should be up to date on their age-appropriate vaccinations, and they should avoid use of live, inactivated and mRNA vaccines during use.
On November 10, 2022, the FDA advised consumers against the use of Sangter Natural Male Energy Supplement. This product is marketed as a natural sexual enhancement agent and is sold on various websites and in retail stores. A laboratory analysis conducted by the FDA confirmed that this supplement contains sildenafil, the active ingredient in Viagra. Viagra is a prescription medication approved for the treatment of erectile dysfunction and must be used under supervision of a licensed health care professional. Sildenafil interacts with nitrates, a class of medications often used in patients with high blood pressure, heart disease, high cholesterol and diabetes. The interaction between sildenafil and nitrates could lower blood pressure to dangerous levels. The FDA encourages patients to use caution when taking “all natural” supplements marketed as dietary supplements or sexual enhancers. These products may contain potentially harmful hidden ingredients which could interact with a patient’s pre-existing conditions or medications. People who have had an adverse event due to taking a supplement should report them to the FDA’s MedWatch Adverse Event Reporting Program.
On November 15, 2022, the U.S. Food and Drug Administration (FDA) issued a Federal Register notice, announcing their plan to improve access to naloxone products. This effort will consider switching certain naloxone products to nonprescription status to prevent and reduce overdose deaths in individuals with substance use disorders. Naloxone can be administered into the muscle or under the skin using an autoinjector or into the nose using a nasal spray in the event of an opioid overdose to rapidly reverse the effects and restore normal breathing. With this, the risk of fatal overdose can be reduced when naloxone is available for rapid administration in homes and other settings of individuals with opioid use disorders. In the Federal Register notice, a preliminary assessment by the FDA suggested that autoinjectors up to 2mg and nasal sprays up to 4mg may be considered safe and effective for nonprescription use. This will not result in an immediate, automatic switch to nonprescription status, as the FDA needs additional information before approving these products for use without a prescription. To support this, the FDA is encouraging pharmaceutical companies to develop and submit applications for the strengths and dosage forms considered safe and effective for nonprescription use. This consideration for easier access to naloxone products aligns with the FDA Overdose Prevention Framework, the FDA’s initiative to address the national overdose public health crisis.
Orphan Drug Approval: Elahere™ (mirvetuximab soravtansine-gynx)
Oral tablet approved for the treatment of a type of active inflammatory arthritis of the spine known as non-radiographic axial spondyloarthritis (nr-axSpA). It has been approved in adult patients with signs of inflammation that have had an inadequate response or intolerance to tumor necrosis factor (TNF) blocker therapy. [10/21/2022 – ABBVIE]
New Biosimilar Product: Rezvoglar™ (insulin glargine-aglr)
Long-acting subcutaneous insulin injection approved for improved blood sugar control in adults and children with diabetes mellitus, approved to be interchangeable with Lantus®. [11/16/2022 – ELI LILLY CO]
Denavir® (penciclovir) 1% cream
Indication: Treatment of recurrent cold sores in adults and children 12 years and older
Dosage Form/Strength: 1% cream, 5 gram tube
Average Wholesale Price (AWP): Generic = $175 | Brand = $195
