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Limited Distribution Updates

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 five LD deals that have been publicly confirmed subsequent to their approvals.

Orsini Specialty Pharmacy to Distribute Adzynma 

Orsini Specialty Pharmacy has been selected by Takeda Pharmaceuticals as the exclusive specialty pharmacy partner for ADZYNMA (ADAMTS13, recombinant-krhn) for prophylactic or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP). ADZYNMA is the first and only FDA-approved recombinant ADAMTS13 (rADAMTS13) enzyme replacement therapy for people 

Onco360 to Distribute Fruzaqla

Onco360 has been selected as a pharmacy partner by Takeda for Fruzaqla (fruquintinib an oral targeted therapy for certain adults with metastatic colorectal cancer (mCRC).  Fruzaqla is the first and only selective inhibitor of all three VEGF receptor kinases approved in the U.S. for previously treated mCRC regardless of biomarker status. Fruzaqla is a selective oral inhibitor of VEGFR-1, VEGFR-2, and VEGFR-3, which play a pivotal role in blocking tumor angiogenesis.

Biologics by McKesson to Distribute Truqap

Biologics by McKesson announced that it has been selected by AstraZeneca as a specialty pharmacy provider for Truqap (capivasertib), an orally administered drug, in combination with fulvestrant, for the treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1, or PTEN).

Walgreens’ (WBA) AllianceRx Pharmacy to  Distribute XDEMVY

Walgreens Boots Alliance’s WBA wholly-owned subsidiary — AllianceRx Walgreens Pharmacy — will distribute Tarsus Pharmaceuticals’  XDEMVY (lotilaner ophthalmic solution) 0.25%. AllianceRx Walgreens is one of the four specialty pharmacies selected to distribute the FDA-approved treatment for Demodex blepharitis (DB), a highly prevalent eyelid disease.

Biologics by McKesson to Distribute Ogsievo

Biologics by McKesson has been selected by SpringWorks Therapeutics as a limited distribution specialty pharmacy for Ogsiveo (nirogacestat). Ogsiveo is a gamma-secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.

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FDA Approves Infused Tx for GVHD – Niktimvo

……………………. catching up on FDA Approvals The FDA recently approved a new infused therapy, Niktimvo (axatilimab-csfr) from Incyte Corporation and Syndax Pharmaceuticals, indicated for the treatment

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