July 7 RxAdvocate July, 2024 — Newsletter
July Stories:
- ACIP Revises Adult RSV Vaccine Recommendations
- FDA Approves 3rd Stelara Biosimilar
- Alzheimer’s Disease
- Happy Independence Day
ACIP Revises Adult RSV Vaccine Recommendations
The Center for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) met June 26th, 2024, and voted to recommend that all adults 75 years of age and older, as well as adults 60-74 years of age who are at risk of respiratory syncytial virus (RSV)-related lower respiratory tract disease, should receive the RSV vaccine for the 2024-2025 RSV season. The new recommendations replace weaker recommendations made by the CDC in 2023 that people 60 years of age and older may receive the vaccine.
RSV is a common respiratory virus that usually causes mild, cold-like symptoms; however, it can cause serious illness in infants, some young children, and older adults. RSV season generally starts in the fall and peaks in the winter in most of the United States. According to the CDC, in the United States, RSV infection leads to approximately 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths among older adults annually. As part of the Affordable Care Act (ACA), payers are required to cover vaccines according to ACIP recommendations with no member cost share.
On July 1, 2024, Sandoz announced that the FDA approved Pyzchiva (ustekinumab-ttwe) as an interchangeable biosimilar to Janssen’s Stelara (Ustekinumab). Developed by Samsung Bioepis, Pyzchiva is approved for psoriatic arthritis, Crohn’s disease, and all other indications approved for the reference medicine, according to a press release from Sandoz, the company that will oversee U.S. commercialization of the biosimilar. Pyzchiva marketing begins February 2025, based on a licensing agreement with Janssen. Pyzchiva will be available in multiple formulations including a subcutaneous injection and an intravenous (IV) infusion. Pricing information is unavailable at this time.
Two other biosimilars of Stelara have already been FDA-approved: Selarsdi (ustekinumab-aekn), approved in April 2024, and Wezlana (ustekinumab-auub), approved in November 2023. Wezlana was also approved with an interchangeability status. At least four other Stelara biosimilars are under FDA review with several others on the horizon.
Alzheimer’s Disease
Alzheimer’s Disease is an irreversible and progressive brain disorder that affects memory and thinking. The brain disorder causes brain cells to lose connection with other brain cells, which in return causes the brain cells to stop functioning over the course of years.
Age, typically after age 60, is a risk factor for Alzheimer’s Disease. A few other risk factors could be having a moderate or severe head injury, having an immediate family member with Alzheimer’s Disease, having heart disease, stroke, high blood pressure, obesity, or diabetes. There is not currently a cure, however, there are several FDA approved medications available. The medications available may help maintain mental function and may slow the symptoms of the disease.
Happy Independence Day
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