Shorla Oncology Announces FDA Orphan Drug Designation for SH-110 to Treat Rare Brain Cancer Using Oral Liquid

User-Friendly Drug to Fight Glioma Will Potentially Help Thousands of Patients in the U.S. with Difficulty Swallowing

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for SH-110, a palatable oral suspension to treat Glioma - a rare brain cancer - by providing a liquid form of treatment for patients who have difficulty swallowing.

While SH-110 will increase coverage and compliance by allowing more flexibility in dose preparation and site of care, its biggest impact will be for patients with Glioma who develop dysphagia, or have difficulty swallowing. These patients often rely on obtaining compounded treatments from a specialized pharmacy or self-compound capsules to fight their disease.

“For too long, many patients with Glioma and their pharmacists and caregivers had no other choice but to break open capsules and expose themselves to unnecessary hazards,” said Sharon Cunningham, chief executive officer of Shorla. “SH-110 is a proprietary product that offers them a safer and more convenient formulation to treat this rare brain cancer.”

SH-110 will join a growing portfolio of patient-friendly cancer medications developed by Shorla that have recently been approved by regulators.

“This is a difference maker in the lives of those who suffer from Glioma,” said Orlaith Ryan, chief technical officer and co-founder of Shorla. “SH-110 complements our other Shorla treatments that are designed to be easier for patients to use, and for caregivers and providers to administer.”

According to the National Brain Tumor Society, about 13,000 adults and 2,000 children are diagnosed each year in the U.S. with Glioma, an orphan disease.

About SH-110

SH-110 is a palatable oral suspension to treat Glioma addressing the unmet medical need for patients with difficulty swallowing. This proprietary product will benefit patients by reducing treatment burden and providing a palatable age-appropriate treatment. SH-110 represents the third oral liquid in Shorla’s growing portfolio of products.

About Shorla Oncology

Shorla Oncology is a privately- held, U.S. and Ireland- based commercial stage specialty pharmaceutical company established by Sharon Cunningham and Orlaith Ryan. The company has an advanced pipeline of innovative oncology drugs for orphan and pediatric cancers. Shorla is focused on indications where existing treatments are limited, in shortage or the drug applications are inadequate for the target population. The company’s growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. Shorla currently markets four products, a reliable supply of Nelarabine for the treatment of T-cell leukemia, JYLAMVO™ an oral liquid methotrexate for the treatment of acute lymphoblastic leukemia and other indications, IMKELDI an oral liquid imatinib for acute lymphoblastic leukemia, chronic myeloid leukemia, gastrointestinal stromal tumors and other indications, and TEPYLUTE® the first and only ready-to-dilute multi-dose vial of thiotepa to treat breast and ovarian cancer.

For further information, please visit https://shorlaoncology.com/pipeline/

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