Shorla Pharma Files FDA Priority Review for T-cell Leukemia Treatment

Irish pharmaceutical company Shorla Pharma Limited (‘Shorla’), has reported that it has successfully filed a priority review application for its SH-111 oncology drug designed to treat T-cell leukemia with the U.S. Food and Drug Administration (FDA).

SH-111 is a life-saving novel therapeutic that is frequently in limited supply, and the company is looking forward to collaborating with the FDA to bring this much-needed medication to market later this year and to meet patient’s urgent needs.

Sharon Cunningham, CEO and Co-founder of Shorla Pharma sated:

“We’re very proud that SH-111 will have a significant clinical benefit particularly for children with leukemia. 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.”

Orlaith Ryan, Shorla Pharma CTO and Co-founder added:

“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.”

T-cell leukemia is a rapidly progressing blood and bone marrow cancer. Whilst most leukemias target older people, T-cell leukemia is the most prevalent type of leukemia in children, and medication for this type of leukemia is often in short supply. The expedited review given to this application by the FDA acknowledges the product’s critical need.

Shorla is a specialist oncology drug development company based in Clomenl, Ireland that focuses on orphan and pediatric cancers. The pharmaceutical company has an advanced portfolio of revolutionary oncology drugs to treat a variety of unmet medical needs, thanks to broad interest from scientists and physicians, as well as an extensive industry network that supports the Children’s Oncology Group in the United States.

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

More 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.

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