Your source for the latest industry trends and drug information news.
Volume 4 | Issue 11
June 1, 2022
Contributors:
Chief Authors: Bonnie Broczkowski & Colleen Peehler
Contributing Author: Ali Zahid, PharmD Candidate; Yi (Eve) Zheng, PharmD/MBA Candidate
On May, 20, 2022, the U.S. Food and Drug Administration (FDA) granted approval to Regeneron Pharmaceuticals, Inc. for Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE) in patients 12 years and older weighing at least 88 pounds. EoE is a chronic immune disorder that is characterized by the presence of eosinophils, a type of white blood cell, in the tissue of the esophagus which causes esophageal inflammation. Common symptoms of EoE include difficulty swallowing and eating, as well as food getting stuck in the esophagus. EoE is a chronic condition which can be medically managed but cannot be cured. This approval of Dupixent® represents the first FDA-approved treatment option for EoE. Dupixent® is an injectable medication that works by inhibiting the inflammatory process. The approval was granted after Dupixent® was studied in a trial, and the results showed a reduction in eosinophil count in the esophagus at week 24 and an improvement in self-reported symptoms of EoE. Patients enrolled in the trial received either placebo or 300 milligrams of Dupixent® every week. The results showed a higher percentage of patients who were treated with Dupixent® achieved the pre-determined level of reduction in esophageal eosinophil count. Patients who were treated with Dupixent® also achieved a greater improvement in self-reported symptoms when compared to the placebo group). The most common side effects associated with Dupixent® included injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections. Dupixent was first approved for use in 2017 and is currently being used to treat other disease states such as atopic dermatitis and asthma. This approval was granted priority review and breakthrough therapy designations for the treatment of EoE.
On May 23, 2022, the FDA announced Teva Pharmaceuticals’ voluntary nationwide recall of a single lot of 0.5 MG anagrelide capsules. Anagrelide is of a class of medications known as anti-platelets that work to slow the production of platelets in the body. Platelets are a type of blood cell that form clots and stop or prevent bleeding. Individuals who suffer from certain blood disorders like thrombocythemia have an overproduction of platelets, which can lead to complications like blood clots, heart attack, or stroke. The recall was initiated due to dissolution test failure. Dissolution is the process in which a dosage form — such as a capsule — forms a solution and is used as a prediction of how a drug is released and becomes available in the body. Incomplete dissolution could result in lower amounts of the medication available in the body to exert its platelet-reducing effect. In patients who are severely ill, with elevated platelet counts, this decrease in anagrelide concentration may increase the risk of clotting and could result in life threatening events like heart attack or stroke. Teva has notified customers of the recall and has asked for return of all recalled product. Patients with questions or concerns about the recall should contact their health care provider. To date, no reports of product complaints or adverse events associated with the recalled product have been made to Teva. Adverse reactions related to the recall should be made to the FDA’s MedWatch Adverse Event Reporting Program.
On May 13, 2022, the FDA approved Eli Lilly’s Mounjaro™ (tirzepatide) injection for the treatment of adults with type 2 diabetes. Mounjaro™ is administered once every week as an injection under the skin. Mounjaro™ is a novel dual-targeting medication that activates glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors. GLP-1 and GIP are both hormones that are involved in blood sugar control. GLP-1 receptor agonists (GLP-1 RA) have been on the market for years and have been proven to help patients control their blood sugar and reduce the risk of cardiovascular disease. Mounjaro is the first diabetes agent approved for use by the FDA that works by acting on the GIP receptors. The approval was granted after results from five clinical trials showed safety and efficacy of Mounjaro™ when compared against, or in combination with, placebo and other diabetes medications. Patients who received the maximum recommended weekly dose of Mounjaro™ (15 milligrams) had significantly lower hemoglobin A1c (HbA1c) levels when compared to placebo (1.6% lower), long-acting insulins degludec (Tresiba®) and glargine (Lantus®) (0.9%-1.0% lower), and the GLP-1 RA semaglutide (Ozempic®) (0.5% lower). Mounjaro™ was also shown to have a significant impact on weight loss, with participants who received the maximum dose having an average weight loss of 15 pounds more than those who received placebo. In patients who received insulin in combination with placebo or Mounjaro™, the average weight loss was 23 pounds higher in the Mounjaro™ treatment group. Patients who received the maximum dose of Mounjaro™ experienced an average weight loss 12 pounds greater than those who received semaglutide, a GLP-1 RA which carries an FDA approved indication for weight loss. Of note, patients who received insulin without Mounjaro™ ended up gaining weight during the study. Side effects of Mounjaro™ are similar to those seen with traditional GLP-1 RA’s (Ozempic®, Trulicity, etc.) on the market, and include nausea, vomiting, diarrhea, decreased appetite, constipation, upper abdominal discomfort and abdominal pain. Mounjaro™ should not be used in patients with a personal or family history of medullary thyroid cancer, Multiple Endocrine Neoplasia syndrome type 2, or type 1 diabetes. Mounjaro™ has not been studied in patients with a history of pancreas inflammation (pancreatitis).
Novel Drug Approval: Mounjaro™ (tirzepatide)
Subcutaneous injection approved to improve blood sugar control in adults with type 2 diabetes. [05/13/2022 – Priority Review – ELI LILLY]
New Drug Approval: Voquezna® (vonoprazan, amoxicillin, and clarithromycin)
Oral capsules and tablets to treat Helicobacter pylori infection. [05/03/2022 – Priority Review – PHATHOM PHARMACEUTICALS, INC.]
Pentasa® (mesalamine)
Indication: To treat the symptoms of Ulcerative Colitis alone or in combination with other medications.
Dosage Form/Strength: 500 MG ER Capsules
Average Wholesale Price (AWP): Generic = $196.75 | Brand = $218.61
