Your source for the latest industry trends and drug information news.
Volume 6 | Issue 19
October 1, 2024
Contributors:
Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Salome Mawi, PharmD/MBA Candidate and Xintian Wu, PharmD/MBA Candidate
On September 13, 2024, the U.S. Food and Drug Administration (FDA) approved Ebglyss™ (lebrikizumab-lbkz), a new biologic treatment for moderate-to-severe atopic dermatitis that is uncontrolled with topical therapies. Atopic dermatitis, or eczema, is an inflammatory condition that causes skin to be dry, itchy and inflamed. Symptoms can vary from person to person, in addition to the range of affected areas, although typically individuals will experience dry, cracked skin, itchiness, a rash or small raised bumps. Ebglyss™, developed by Eli Lilly and Company, reduces skin inflammation throughout the body by targeting an inflammation regulator known as IL-13.The medication is approved for adults and children at least 12 years old and 88 pounds with moderate-to-severe- eczema that is uncontrolled with topical prescription medications. Ebglyss™ is an injection that can be given with or without topical corticosteroids. Injections are given every two weeks until week 16, or once an adequate clinical response is achieved; then a patient may transition to a single monthly maintenance injection.
Approval of the medication is based on the results of the ADvocate 1, ADvocate 2, and ADhere studies where the primary endpoint was evaluated at 16 weeks and measured as clear or almost clear skin. Over 1,000 adults and children with moderate-to-severe-eczema uncontrolled by topical medications were included and results found that 38% of individuals who received Ebglyss™ achieved clear or almost clear skin at week 16 and 10% saw results four weeks early. Furthermore, 77% of patients maintained these results at one year with monthly dosing. Side effects of the medication include eye and eyelid inflammation, injection site reactions and shingles. The medication will be available in the coming weeks in the United States and the manufacturer, Eli Lilly and Company, will offer a patient support program, including copay assistance, for eligible patients.
On September 12, 2024, the FDA added a warning that Veozah® (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. The warning follows a post-marketing report where a patient with elevated liver blood test values was experiencing symptoms of liver injury after taking the medicine for about 40 days. The symptoms included feeling more tired than usual, nausea, vomiting, unusual itching, light-colored stools, and yellowing of the eyes or skin, called jaundice. If you experience any of these symptoms, stop taking Veozah® immediately and contact your health care professional who prescribed the medication. Health care professionals should order liver function blood tests for patients before prescribing Veozah®, then do follow-up tests every month for the first three months, then again at months 6 and 9 of treatment. Adverse reactions or quality problems associated with the product should be reported to the FDA’s MedWatch Adverse Event Reporting program.
On September 12, 2024, the U.S. Food and Drug Administration (FDA) authorized the first over-the-counter (OTC) hearing aid software, Hearing Aid Feature (HAF). HAF is a mobile medical application intended for use with compatible versions of the Air Pods Pro. Consumers can adjust the HAF based on their hearing needs without the assistance of a hearing professional. The HAF can be set up using an iOS device, and the hearing levels are accessed from the iOS HealthKit to customize it. The volume, tone and balance can be adjusted after the setup of HAF. The compatible versions of Air Pods Pro and HAF are intended to amplify sounds for those older than 18 years with mild to moderate hearing impairment. The FDA reviewed HAF software under the De Novo premarket review pathway, used for low to moderate risk novel devices, and authorization was granted to Apple Inc.
New Dosage Form: Ocrevus Zunovo™ (ocrelizumab and hyaluronidase-ocsq)
Subcutaneous injection approved for the treatment of primary progressive and relapsing forms of multiple sclerosis in adult patients. This provides an alternative to IV administration required when using Ocrevus® [9/13/24 – Genentech Inc.]
Indication: Once-daily tablets for certain types of cancers called Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) and Philadelphia chromosome-positive acute lymphocytic leukemia (Ph+ ALL).
Dosage Form/Strength: 100mg
Average Wholesale Price (AWP): Generic = $20,801 | Brand = $21,896
Indication: Treatment for partial-onset seizures in patients 6 years and older.
Dosage Form/Strength: 600mg
Average Wholesale Price (AWP): Generic = $785 | Brand = $827
