Drug Pipeline & Clinical Update - May 2026

Judi Health closely monitors the drug landscape to provide our clients with timely information on newly FDA approved medications and products in the pipeline. Please find the May 2026 Monthly Drug Update below:

Key New Drug Approvals

Jakafi XR™ (ruxolitinib) oral tablet

‍Approval Date: 05/01/2026 ‍

Indication: Treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis in adults; treatment of polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea; treatment of steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older; treatment of chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.‍

Cost*: TBD

Key Consideration:

• Received orphan drug designation by the FDA
• Once-daily XR version of Jakafi®, shown to provide consistent, day-long exposure comparable to twice daily Jakafi®

Press Release: Incyte Announces FDA Approval of Jakafi XR™ (ruxolitinib) Extended-Release Tablets for the Treatment of Myelofibrosis, Polycythemia Vera and Graft-Versus-Host Disease

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Veppanu^TM (vepdegestrant) oral tablet

Approval Date: 05/01/2026

Indication: Treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer whose disease progressed following at least one line of endocrine therapy

Cost*: TBD

Key Consideration:

• First and only FDA approved PROteolysis TArgeting Chimera (PROTAC), a heterobifunctional protein degrader therapy

Press Release: Arvinas Announces FDA Approval of VEPPANU (vepdegestrant) for the Treatment of ESR1m, ER+/HER2- Advanced Breast Cancer

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Beqalzi^TM (sonrotoclax) oral tablet

Approval Date: 05/13/2026

Indication: Treatment of relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor

Cost*: TBD

Key Consideration:

• Received priority review and orphan drug designation by the FDA
• The first and only FDA approved BCL2 inhibitor for relapsed/refractory mantle cell lymphoma

Press Release: BeOne Medicines’ BEQALZI™ (sonrotoclax) Approved by U.S. FDA as First and Only BCL2 Inhibitor for R/R Mantle Cell Lymphoma

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Trimbow® (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) oral inhaler

Approval Date: 05/14/2026

Indication: Maintenance treatment of asthma in adults

Cost*: TBD

Key Consideration:

• Triple therapy single-inhaler for asthma

Press Release: U.S. FDA approves TRIMBOW® - Chiesi’s Single Inhaler Triple Therapy - for the maintenance treatment of asthma in adults

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Baxfendy^TM (baxdrostat) oral tablet

Approval Date: 05/15/2026

Indication: Treatment of hypertension in combination with other antihypertensive drugs, to lower blood pressure in adults who are not adequately controlled on other agents

Cost*: TBD

Key Consideration:

• First and only aldosterone synthase inhibitor approved by the FDA for treatment of hypertension
• Received priority review by the FDA

Press Release: Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension

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Notable Expanded Indications

• Auvelity® (dextromethorphan/ bupropion) – expanded to treat agitation associated with dementia due to Alzheimer’s disease
• Inqovi® (decitabine; cedazuridine) – expanded to treat newly diagnosed acute myeloid leukemia (AML), in combination with venetoclax, in patients at least 75 years of age or who have comorbidities that preclude use of intensive induction chemotherapy
• Linzess® (linaclotide) – expanded to treat functional constipation in patients 2 years of age and older
• Uptravi® (selexipag) – expanded to treat pulmonary arterial hypertension (PAH) in patients 2 years of age and older

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Generic Launches

• Astagraf XL® (tacrolimus) oral capsule

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*Cost: actual patient out-of-pocket costs may be lower, as the list price does not reflect insurance coverage, co-pay support for eligible patients, or financial assistance from patient support