Shorla Pharma Announces FDA Filing Acceptance and Priority Review for T-cell Leukemia Treatment

Biopharma company prepares for launch of first US product

CLONMEL, Ireland--(BUSINESS WIRE)--Shorla Pharma Limited (‘Shorla’), a specialty pharmaceutical company, has announced today that it has submitted, and the U.S. Food and Drug Administration (FDA) has accepted for filing, its application for its SH-111 oncology drug designed to treat T-cell leukemia. SH-111 is a lifesaving treatment that is often in shortage and the company looks forward to working closely with FDA to bring this much needed product to market later this year.

“We’re very proud that SH-111 will have a significant clinical benefit particularly for children with leukemia,” said Sharon Cunningham, CEO and Co-founder of Shorla Pharma. “It’s a desperately needed product and a life-changing treatment that we are honored to bring to patients in the United States, and later, worldwide.”

Founded in Ireland, Shorla specializes in developing innovative oncology drugs, with a focus on orphan and pediatric cancers. With strong support from scientists and clinicians, plus an extensive industry network that includes the Children’s Oncology Group in the U.S., the company has an advanced pipeline of oncology therapies to treat a number of unmet patient needs.

T-cell leukemia is an aggressive blood and bone marrow cancer which progresses quickly. While most leukemias target older people, T-cell leukemia is most common among children, with this particular treatment often in shortage. The expedited review granted for this filing recognizes the urgent need for the product.

Added Orlaith Ryan, Shorla Pharma CTO and Co-founder, “Reaching this milestone is an important step as we continue to make progress across our growing pipeline. Our focus is on developing innovative oncology treatments for women and children, with a focus on rare cancers where existing treatments are limited, in short supply or inadequate.”

The company is also developing a drug for treating breast and ovarian cancers, and an oral solution to treat patients with glioblastoma who have trouble swallowing.

About Shorla Pharma Ltd

Established in 2018 by Sharon Cunningham and Orlaith Ryan, Shorla Pharma Ltd is a privately held, specialty pharmaceutical company with an advanced pipeline of innovative oncology drugs for women's, orphan and pediatric cancers. The company concentrates on indications where existing treatments are limited, in shortage or inadequate for the target population. Shorla's growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care.

For further information, please visit www.shorlapharma.com.