Rx Insights from September '25

This month's edition provides a focused review of newly approved and recently launched therapies. Expion Health monitors these developments closely to assess clinical relevance, therapeutic positioning, and potential implications for payers, providers, and patients.

WAYRILZ (rilzabrutinib)

Indication: BTK inhibitor for adults with persistent or chronic immune thrombocytopenia (ITP) with insufficient prior response.

Clinical Data: Phase 3 LUNA-3 trial (n=202): 23% achieved durable platelet response at Week 25 vs 0% placebo (p<0.0001).

BILDYOS & BILPREVDA (denosumab-nxxp)

Indication: The fifth FDA-approved biosimilars to Prolia and Xgeva respectively, covering osteoporosis, bone metastases, and giant cell tumor of bone indications. Not interchangeable with the reference products at this time.

LEQEMBI IQLIK (lecanemab-irmb)

Indication: First and only FDA-approved at-home amyloid beta-directed antibody maintenance treatment for early Alzheimer's disease.

Clinical Data: CLARITY AD OLE trial: systemic reactions were less common with subcutaneous dosing (<1%) vs IV infusions (~26%).

INLEXZO

Indication: First FDA-approved drug-device combination for sustained intravesical chemotherapy in BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC).

Clinical Data: Phase IIb SunRISe-1 trial (n=85): 82% complete response rate, with 51% maintaining response for 12+ months.

ENBUMYST

Indication: Intranasal loop diuretic for edema associated with congestive heart failure, hepatic disease, and renal disease.

FORZINITY (elamipretide)

Indication: Accelerated approval to improve muscle strength in Barth syndrome patients weighing 30 kg+.

INLURIYO (imlunestrant)

Indication: Estrogen receptor antagonist for ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.

Clinical Data: Phase 3 EMBER-3 trial: median PFS of 5.5 vs 3.8 months vs investigator's choice therapy (p=0.0008).

PALSONIFY (paltusotine)

Indication: First-line oral treatment for acromegaly after inadequate response to surgery.

Clinical Data: PATHFNDR-1 trial (n=111): 56% achieved normalized IGF-1 vs 5% placebo.