New Dosage Form for TPOXX

An intravenous (IV) form of the smallpox treatment drug, TPOXX® (tecovirimat – SIGA Technologies, Inc.), gained approval from the U.S. Food and Drug Administration (FDA) on May 18, 2022. As an orthopoxvirus VP37 envelope wrapping protein inhibitor, it interferes with the ability of the virus that causes smallpox to spread and infect body cells. It initially was FDA approved in July 2018 as oral capsules, but critically ill patients may not be able to swallow an oral medication. Smallpox virus no longer circulates naturally, but samples of it are kept in laboratories. Potentially, it could be spread from an accidental release or from bioterrorism. Although vaccines are available to prevent smallpox, they no longer are given routinely. Through an agreement with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), SIGA supplies both forms of TPOXX to the U.S. government’s Strategic National Stockpile of drugs and medical supplies to be used for emergencies. Off-label, TPOXX has been used to treat monkeypox, a disease similar to smallpox..

COVID-19 Vaccine Booster FDA Authorized for Young Children

The FDA extended an emergency use authorization (EUA) for Pfizer/BioNTech’s COVID-19 vaccine on May 17, 2022. It now is authorized as a booster for children between the ages of five years and 12 years old. Administered as a single 10mcg (0.2mL) intramuscular (IM) injection, it will be given five months or longer after the child receives two initial doses that are 21 days apart. For children younger than 12 years old, only vaccine that is packaged in vials with orange caps and orange label borders should be used. The vaccine also has an EUA for vaccinating and boosting patients who are at least 12 years old; as well as an EUA for one or two booster doses for adults. Branded as Comirnaty® (COVID-19 vaccine, mRNA), Pfizer/BioNTech’s COVID-19 vaccine is FDA approved for adults as a primary series of two 30mcg doses separated by three weeks..

Mounjaro™ (tirzepatide)

On May 13, 2022, Eli Lilly and Company’s Mounjaro™ (tirzepatide) injection was approved by the U.S. Food and Drug Administration (FDA). It is the first drug that includes both a glucagon-like peptide-1 (GLP-1) receptor agonist and a class of antidiabetes agents called glucose-dependent insulinotropic polypeptides (GIP). To be used along with increased exercise and modified diet, it is indicated for treating adults who have type 2 diabetes. Doses are injected subcutaneously (SC) once a week using single-dose, self-injector pen devices. Starting at 2.5mg/week, the recommended dose then doubles to 5mg/week after one month. If further increases are needed to manage blood sugar levels, doses may be increased by 2.5mg/week at intervals of no less than one month. The maximum recommended dose is 15mg per week. Mounjaro has a boxed warning about the potential for certain cancers that is common to all GLP-1 agonists. A definite launch date and pricing have not yet been announced. .

At a Glance

• Brand (Generic) Name: Mounjaro (tirzepatide)
• Manufacturer: Eli Lilly
• Date Approved: May 13, 2022
• Indication: adjunctive to diet and exercise for improving glycemic control for adults who have type 2 diabetes
• Dosage Forms Available: single-dose, auto-injectors containing 2.5mg, 5mg, 7.5mg, 10mg 12.5mg or 15mg of Mounjaro for SC injection
• Launch Date: within the coming weeks
• Estimated Annual Cost: Currently unavailable
• According to the Centers for Disease Control and Prevention’s National Diabetes Statistics Report, 28.5 million American adults are known to have type 2 diabetes, with up to 8.5 million more not yet diagnosed and approximately 96 million others having prediabetes.
• Mounjaro is the first FDA-approved drug to combine a GIP and a GLP1. It promotes the production of natural insulin and increases insulin sensitivity.
• About 1,800 participants who had type 2 diabetes, an elevated risk for cardiovascular (CV) disease, an average weight of 90.5kg (199 pounds) and an average beginning hemoglobin A1c (HbA1c) of 8.5%, completed the open-label, year-long phase III SURPASS-4 clinical study. All patients continued treatment with an oral antidiabetes regimen that could include metformin, a sulfonylurea and/or a sodium-glucose cotransporter-2 (SGLT-2) inhibitor. Some patients also received injections of insulin glargine. Others injected 5mg, 10mg or 15mg of Mounjaro per week. Depending on the dose, the HbA1c for those using Mounjaro decreased by an average of 2.2% to 2.6% versus an average decline of 1.4% for patients using insulin glargine.
• Results of four other phase III trials that compared Mounjaro with either placebo, Ozempic® (semaglutide) or Tresiba® (insulin degludec) were comparable to results from SURPASS-4.
• Although Mounjaro is not indicated for weight loss, patients who were obese and who used the highest recommended dose (15mg/week) in clinical trials lost an average of 11.7kg (25.8 pounds) compared to an average increase of 1.9kg (about 4 pounds) for those using a placebo or another antidiabetes drug.
• In clinical studies, the most common side effects were mild-to-moderate gastrointestinal (GI) issues, such as constipation, diarrhea, indigestion and nausea.
• As with other GLP-1 agonists, the labeling for Mounjaro contains a boxed warning about tumors of the thyroid gland (thyroid C-cell tumors) that have occurred among laboratory rodents treated with some GLP-1 receptor agonists in preclinical studies. However, whether the drugs cause humans to develop thyroid C-cell tumors, such as medullary thyroid carcinoma (MTC), is not yet known. Patients who have MTC, individuals with close family members who have thyroid C-cell tumors and patients who have Multiple Endocrine Neoplasia syndrome type2 (tumors in more than one gland) should not use any drug in the class.
• GLP-1 agonists available to treat diabetes include orally-administered Rybelsus® (semaglutide) tablets and the SC-injected drugs once-weekly Bydureon® (exenatide), Ozempic and Trulicity® (dulaglutide); once-daily Adlyxin® (lixisenatide) and Victoza® (liraglutide); and twice-daily Byetta® (exenatide).