Orsini Specialty Pharmacy, an Illinois-based company involved in rare disease pharmacy solutions, announced on Monday that it has been chosen by Massachusetts-based KalVista Pharmaceuticals as a specialty pharmacy partner for EKTERLY (sebetralstat), an FDA-approved oral therapy for the treatment of acute attacks of hereditary angioedema (HAE) in adult and paediatric patients aged 12 years and older.
HAE is a life-threatening inherited genetic disorder that can affect the autoimmune system, causing recurrent episodes of severe swelling, most commonly in the limbs, face, intestines and airway. The condition is a result of low levels or improper functioning of a protein called C1 inhibitor. While minor trauma or stress could trigger an attack, swelling often occurs without a known trigger.
EKTERLY is administered at the onset of an HAE attack to quickly relieve symptoms and reduce the severity and duration of the episode. It is the tenth HAE therapy to join Orsini's portfolio.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval