New Indication for Botox Cosmetic
On Oct. 18, 2024, the US Food and Drug Administration (FDA) approved Botox® Cosmetic (onabotulinumtoxin A – Allergan) for the temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults. The platysma muscle covers the neck and lower face and when contracted causes the appearance of bands, which are vertical lines across the neck, and create a less defined jawline. Botox Cosmetic is an acetylcholine release inhibitor and a neuromuscular blocking agent. It works by blocking nerve impulses and reducing movement to the muscles in the targeted area. Botox Cosmetic has been on the market since 2002; it was originally approved to temporarily improve the appearance of moderate to severe glabellar lines (frown lines between the brows). This is the first and only product with this new indication, beyond the face. The recommended dose for platysma bands is 26, 31, or 36 units, depending on severity, along the jawline and vertical bands connecting the jaw and neck. Full prescribing information can be found here.
Sterlara Biosimilar, Selarsdi, Now Approved for Crohn’s Disease and Ulcerative Colitis
Selarsdi™ (ustekinumab-aekn – Alvotech and Teva), a biosimilar to the subcutaneously (SC) injected form of Johnson & Johnson Innovative Medicine’s Stelara® was approved in April 2024 for plaque psoriasis and psoriatic arthritis (PsA) for patients who are at least six years old and who are eligible for phototherapy or systemic therapy. On Oct. 22, 2024, the FDA approved Selarsdi 130mg/26mL in a single dose vial for intravenous (IV) infusion for use in adults with Crohn’s disease and ulcerative colitis (UC). Ustekinumab inhibits interleukins 12 and 23 (IL-12 and IL-23) and interrupts processes involved in chronic inflammation. Recommended dosing for Crohn’s disease and UC is a single IV infusion using weight-based dosing, followed by 90mg SC, available in prefilled syringes, every eight weeks. Patients who use ustekinumab may be more susceptible to acquiring infections, including tuberculosis (TB), and of developing cancer. Selarsdi will be marketed in the U.S. under a settlement agreement that allows its release for sale by Feb. 21, 2025. For its prescribing information click here.
Pyridostigmine Bromide Extended-Release Tablets Approved for US Armed Services
The FDA approved pyridostigmine bromide extended-release (PB ER) tablets on Oct. 4, 2024, for the pretreatment against lethal effects of soman nerve agent poisoning in adults. The Amneal announcement came on Oct. 21, 2022, stating that this was developed for adults in the US Armed Services and US allies and was partly funded by the US government. Soman is a toxic, chemical warfare nerve agent originally developed as an insecticide, which may have been used in the 1980s Iran-Iraq war. It interferes with the functioning of the central nervous system causing a range of symptoms including convulsions, paralysis, and death, and is one of the most toxic chemical warfare agents. Pyridostigmine bromide is an acetylcholinesterase inhibitor, thereby enhancing the transmission of nerve impulses. Pyridostigmine bromide is dosed every eight hours compared to once-daily dosing for PB ER. The recommended dose is one oral 105mg tablet per day, starting at least several hours prior to exposure to soman. Patients should discontinue use at the first sign of soman nerve agent poisoning; atropine and pralidoxime should be administered immediately. Continued use of PB ER should be evaluated after 14 days of therapy. Here is the full prescribing information.
Gilead Withdraws Urothelial Cancer Indication for Trodelvy
On Oct. 18, 2024, Gilead announced it would be voluntarily withdrawing the accelerated approval for Trodelvy® (sacituzumab govitecan-hziy) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. Based on positive phase II results, Trodelvy received accelerated approval on April 13, 2021; however, the phase III study did not meet the primary endpoint of overall survival. The FDA consulted on Gilead’s decision, and it does not affect the other approved indications. Trodelvy is a Trop-2-directed antibody and topoisomerase inhibitor conjugate approved for certain patients with metastatic breast cancer. Prescribing information will be available at: https://www.trodelvy.com/
Abrysvo Approved for Adults under 50
Pfizer announced that the FDA approved Abrysvo® (respiratory syncytial virus [RSV] vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults 18 through 59 years of age who are at increased risk for LRTD caused by RSV on Oct. 22, 2024. Those at an increased risk for LRTD include individuals with chronic conditions like obesity, diabetes, chronic obstructive pulmonary disease, heart failure, chronic kidney disease, or asthma. This represents about 9.5% of adults aged 18-49 years in the US. Abrysvo works by keeping a part of RSV from changing shape to merge with body cells, keeping the virus more susceptible to immune activity. The recommended dose is one injection (0.5mL) administered intramuscularly (IM). Abrysvo was first approved in 2023 for vaccinating adults over 60 years of age with a second indication for pregnant individuals at 32-36 weeks of gestation to protect infants from birth up to six months of age later that year. This is the first and only RSV vaccine indicated for adults under 50 years of age and remains the only one approved for women late in pregnancy. In June 2024, the Center for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) updated vaccine recommendations for RSV to only include adults aged 75 years and older and 60-74 years of age if they are at increased risk for severe RSV. ACIP will need to include adults under 50 years old in their recommendations before the vaccine is widely prescribed in this population. Here is the full prescribing information.