Tipperary-based company Shorla Pharma has filed an application with the US Food and Drug Administration (FDA) to bring its speciality oncology drug designed to treat T-cell leukaemia to market later this year.
The SH-111 drug is a lifesaving treatment that is often in shortage. “We’re very proud that SH-111 will have a significant clinical benefit particularly for children with leukaemia,” said Sharon Cunningham, CEO and Co-founder of Shorla Pharma.
“It’s a desperately needed product and a life-changing treatment that we are honoured to bring to patients in the United States, and later, worldwide.”
Shorla specialises in developing innovative oncology drugs, with a focus on orphan and paediatric 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 leukaemia is an aggressive blood and bone marrow cancer which progresses quickly. While most leukaemia target older people, T-cell leukaemia is most common among children, with this particular treatment often in shortage.
Shorla Pharma co-founder Orlaith Ryan said: “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.