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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.

PANTHERx Rare to Distribute Filsuvez

PANTHERx Rare was selected by Chiesi Global Rare Diseases for the Distribution of FilsuvezĀ® (birch triterpenes) topical gel. Filsuvez is the first approved treatment for wounds associated with both dystrophic and junctional epidermolysis bullosa (EB) in adult and pediatric patients 6 months of age and older.

Onco360 to Distribute Xpovio

Onco360, is now the national specialty pharmacy network partner for Karyopharmā€™s product Xpovio (selinexor), a first-in-class, XPO-1 inhibitor. Xpovio is approved in multiple oncology indications, including: (i) in combination with VelcadeĀ® (bortezomib) and dexamethasone (XVd) in patients with multiple myeloma after at least one prior therapy; (ii) in combination with dexamethasone in patients with heavily pre-treated multiple myeloma; and (iii) in patients with diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy.

Walgreens to Distribute Vivjoa

Walgreens specialty pharmacy patients now have exclusive access to Vivjoa, through AllianceRx Walgreens Pharmacy, a subsidiary of Walgreens. Vivjoa (oteseconazole), manufactured by Mycovia Pharmaceuticals, Inc., is the first FDA-approved medication to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in post-menopausal women or women who are not of reproductive potential.

PromptCare to Dispense Coagadex 

PromptCare has been selected by Kedrion Biopharma to dispense Coagadex, a limited-distribution therapy approved in 2015 by the U.S. Food and Drug Administration (FDA) for the treatment of factor X deficiency. Coagadex is the first and only FDA-approved therapy to treat hereditary factor X deficiency and is the only factor X concentrate available worldwide.

Amber Specialty Pharmacy to Dispense Rezdiffra

Amber Specialty Pharmacy announces that it will begin dispensing Madrigal’s Rezdiffraā„¢, a medication recently approved by the FDA for the treatment of non-alcoholic steatohepatitis (NASH). Rezdiffra (resmetirom) is the first and only FDA-approved once-daily treatment for adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

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