September 9 RxAdvocate September, 2025 — Newsletter
Posted at 16:29h
in
Newsletter
by FTHD
September Stories:
- Wegovy Newest Indication Approval for MASH
- Migraine Treatment Sees 2 New Drug Approvals in 2025
- One Big Beautiful Bill
- End of Summer Wrap Up
Wegovy Newsest Indication Approval for MASH
On August 15th, the FDA approved Wegovy (semaglutide) for the treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) for adults with moderate to advanced fibrosis. This indication is not associated with a specific BMI and does not stipulate the patient must be obese or overweight. Currently, Rezdiffra is the only other medication to have accelerated approval for treatment of MASH(March 2024) which carries a $50,000 annual price, compared to Wegovy which annually costs $17,500. In Phase 3 Wegovy is showing results similar to Rezdiffra, and with obesity and cardiovascular issues being top concerns for patients with MASH, Wegovy is likely to be the favored option for treatment.
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Migraine Treatment Sees 2 New Drug Approvals in 2025
Atzumi, a nasal spray approved for acute treatment of migraine with or without aura in adults, as well as Brekiya, an autoinjector approved for acute treatment of migraine with or without aura and cluster headaches in adults, saw approval in 2025 from the FDA. Both medications use DHE, which have competitors currently on the market, but these medications seek significant improvements on current formulations. Pricing for both medications are still pending, but will likely be a second-line treatment for moderate or severe migraines, especially for patients who have trouble with oral medications due to nausea or vomiting. Both medications should be commercially available later in 2025.
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Additional Resource
Signed into law on July 4, 2025, the “One Big Beautiful Bill” Act (H.R. 1) is a wide-ranging budget reconciliation package aimed at delivering historic tax cuts, strengthening border security, modernizing government systems, and reducing the federal deficit. While not focused exclusively on healthcare, the bill plays a critical role in the Administration’s broader effort to reduce costs for American families—including high prescription drug prices. The White House has positioned the legislation as a key step in aligning U.S. drug costs with international pricing benchmarks, requiring manufacturers to offer their lowest global prices to American consumers.
For employers and pharmacy benefit managers (PBMs), the implications are significant. Lower manufacturer prices, coupled with enhanced federal transparency requirements, will bring increased scrutiny to PBM contracting practices. Hidden fees, spread pricing, and rebate markups are expected to diminish as employers gain clearer visibility into the true cost of prescription benefits. These reforms are designed to shift savings away from intermediaries and back to businesses and employees, giving employers stronger leverage in negotiating fairer, more cost-effective pharmacy benefit arrangements.
These materials are provided for informational and educational purposes. The website links provided are for convenience only. RxConnection is not responsible for the accuracy and validity of the content of those websites.
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Meet the New Team Members!
Strategic Account Executive, Christina Hollis-Sabol, celebrated a joyful milestone this summer by marrying the love of her life, Andrew. We extend our warmest congratulations and best wishes for a lifetime of happiness together.
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Strategic Account Executive, Erica Marquez, recently visited La Quemada in Zacatecas, Mexico. She enjoyed the cooler temperatures, delicious food, and, most importantly, time with family in one of her favorite places.
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Clinical Account Executive, Tori Tebbe, and her family made lasting memories this summer with exciting trips to the Indianapolis Children’s Museum. Savannah (age 3) and Alexandria (age 2) loved every moment of the fun, educational activities and games!
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Account Manager, Scott Lowery, and his family had an unforgettable adventure this summer at Busch Gardens in Williamsburg, Virginia. Together, they packed the day with exciting rides, lively shows, and endless family fun from start to finish!
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Strategic Account Executive, Brittany Maira, spent the 4th of July weekend with her family and her dog, Finlee, at the beach in the Outer Banks of North Carolina. Between the sun, sand, and fireworks, it was a perfect holiday celebration by the shore!
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Account Manager, Kaylee Dunson, enjoyed special family time at a cabin in Broken Bow, OK, with a lively pizza night. From making dough from scratch to piling on favorite toppings, everyone had a blast creating their own personal pizzas!
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