Limited Distribution Deals Confirmed

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the press releases rarely specify the specialty pharmacy(ies) selected as the designated partner(s).

Here are two LD deals that have been recently publicly confirmed subsequent to the approvals.

Soleo Health Selected as Limited Distribution Partner for VYVGART
January 24, 2022 — FRISCO, TX– Soleo Healthannounced today it was selected as a limited distribution partner for VYVGART™ (efgartigimod alfa-fcab) by argenx SE. VYVGART was approved by the U.S. Food & Drug Administration (FDA) on December 17, 2021 for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Soleo Health will manage and administer VYVGART intravenously in patients’ homes or its ambulatory infusion centers nationwide. Patients are supported through Soleo Health’s Myasthenia Gravis Therapeutic Care Management Center (TCMC). The TCMC is staffed with specially trained interdisciplinary teams, comprising experienced therapy care pharmacists, registered nurses, reimbursement specialists and patient care ambassadors dedicated to supporting patients living with myasthenia gravis.

PANTHERx Rare Selected as Exclusive Distribution Partner for FYARRO
Feb. 24, 2022 – PITTSBURGH, PA– PANTHERx Rare announces that it has been selected by Aadi Bioscience as the exclusive U.S. pharmacy distribution partner for new drug FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound). FYARRO, an albumin-bound mTOR inhibitor administered as an injectable suspension, is the first FDA-approved therapy for the treatment of advanced malignant perivascular epithelioid cell neoplasm (PEComa), an ultra-rare sarcoma.

Advanced PEComa is a rare, aggressive subset of soft tissue sarcomas for which there are no other approved therapeutic options. PEComas are composed of histologically and immunohistochemically distinctive epithelioid cells and most commonly arise from visceral, retroperitoneal, and abdominopelvic sites.


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