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Limited Distribution Updates – July 18, 2024

Announcements for newly approved specialty drugs often state that the product will be available through specialty pharmacy in limited distribution. However, the early 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.

Soleo Health to Distribute Ryplazim

Soleo Health has been named a limited distribution specialty pharmacy partner to dispense Ryplazim (plasminogen, human-tvmh), manufactured by Kedrion Biopharma. Ryplazim is the first and only FDA approved therapy for supporting the approximately 500 people in the U.S. affected by plasminogen deficiency type 1 (PLGD-1).

Orsini Specialty to Distribute Olpruva

Orsini Specialty Pharmacy (Orsini), and Zevra Therapeutics, Inc. is now the pharmacy partner for Olpruva (sodium phenylbutyrate) for oral suspension. Olpruva is used along with certain therapies, including changes in diet, for long-term management of certain adult and pediatric patients with urea cycle disorders (UCDs) involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC) or argininosuccinic acid synthetase (AS). 

Biologics by McKesson to Distribute Camcevi

Biologics by McKesson has been selected by Accord BioPharma, Inc. as an exclusive specialty pharmacy provider for Camcevi (leuprolide) 42mg injection emulsion for subcutaneous use. Camcevi is a gonadotropin-releasing hormone (GnRH) agonist indicated for the treatment of adult patients with advanced prostate cancer.

Camcevi was originally approved by the FDA on May 25, 2021.

Optime Care to Distribute Gavreto

Optime Care, an AscellaHealth Company, has been selected to distribute Gavreto by Rigel Pharmaceuticals, Inc. Gavreto, a targeted oral therapy, is used to treat adults with non-small cell lung cancer (NSCLC) that has spread and also adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working caused by abnormal RET genes.

Onco360 to Distribute Rytelo

Onco360 has been selected as a pharmacy partner by Geron Corporation for Rytelo (imetelstat) a first in class oral, oligonucleotide telomerase inhibitor, approved for the treatment of adult patients with low to intermediate risk myelodysplastic syndromes (MDS) with transfusion dependent (TD) anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA).Onco360 Selected as a Limited Distribution Specialty Pharmacy Partner for Rytelo™ (imetelstat).

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