Shorla Pharma seeks FDA approval to launch leukaemia treatment

23 Apr 2021

Company founders Orlaith Ryan and Sharon Cunningham. Image: Shorla Pharma

The Clonmel-headquartered biopharma start-up is preparing for the launch of its first product in the US.

Irish start-up Shorla Pharma is one step closer to launching its leukaemia treatment in the US.

The company announced today (23 April) that it has submitted an application to the US Food and Drug Administration (FDA) for its oncology drug designed to treat T-cell leukaemia. It is expecting that the product could be brought to market later this year.

Clonmel-headquartered Shorla Pharma was founded in 2018 by Sharon Cunningham and Orlaith Ryan, who previously worked together at EirGen Pharma in Waterford.

Their company is developing oncology drugs in areas where existing treatments are limited, in shortage or inadequate for the target population, and it has a focus on cancers affecting women and children.

Its SH-111 drug targets T-cell leukaemia, which is an aggressive blood and bone marrow cancer that is most common among children.

Shorla Pharma said the FDA has granted an expedited review on the application for SH-111 as there is an urgent need for treatments in this area.

“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,” said Cunningham, who is CEO of the start-up.

Ryan, who is CTO, added that reaching the milestone of the FDA application is an “important step” as the company continues to make progress across its growing pipeline.

SH-111 would be the first drug that Shorla Pharma has brought to market. It is also developing a drug for treating breast and ovarian cancers, as well as an oral treatment for patients with glioblastoma who have trouble swallowing.

The start-up raised $8.3m in Series A funding last summer, in a round led by Seroba Life Sciences.

It said at the time that this capital would be used to advance its product pipeline and expand its technical and commercial operations in Ireland and the US.

Sarah Harford was sub-editor of Silicon Republic