A new drug application (NDA) from US-Ireland speciality pharmaceutical company Shorla Oncology has been accepted by the US Food and Drug Administration (FDA) for SH-201, an oral version of the related leukaemia chemotherapy drug. 

The regulatory agency will give a decision on the approval on 30 November 2024 under the Prescription Drug User Fee Act. 

Shorla obtained the rights to SH-201, previously named PIP-101, in July 2023 from an unnamed developer. Under the agreement, the developer was to continue to manufacture the drug until Shorla received an NDA.

Shorla will now be responsible for the launch, commercialisation and sales of SH-201 in the US. 

SH-201 is an oral liquid drug, making the treatment accessible to patients who may struggle with taking tablets or other dosage forms. It slows or stops the growth of certain forms of leukaemia, including chronic myeloid leukaemia and acute lymphoblastic leukaemia.

According to a report on GlobalData’s Pharma Intelligence Center, there will be 17,562 cases of CML in the eight major markets (US, UK, Spain, France, Italy, Germany, Canada, and Japan) in 2030. 

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The company is headquartered in Ireland and has operations in the US. In October 2023, Shorla received $35m in Series B funding round led by Kurma Partners’ Growth Opportunities Fund to boost its oncology portfolio growth by advancing drug candidates such as SH-201.  

In March 2023, the FDA granted approval for Shorla’s Nelarabine injection (SH-111), an oncology drug, to treat T-cell leukaemia, an aggressive blood and bone marrow cancer that progresses quickly. The regulatory approval, which was indicated for T-cell lymphoblastic lymphoma (T-LBL) and T-cell acute lymphoblastic leukaemia (T-ALL), was the company’s first product to receive approval in the US market. 

Shorla added to its oncology portfolio by acquiring the oncology and autoimmune drug Jylamvo (methotrexate) from Therakind for commercialisation in the US market in October 2023, approved in the US to treat adults with acute lymphoblastic leukaemia, mycosis fungoides, relapsed or refractory non-Hodgkin lymphoma, rheumatoid arthritis, and severe psoriasis.   

In the announcement accompanying the NDA, Shorla’s CEO Sharon Cunningham said: “With this NDA acceptance for SH-201, we are a step closer to providing an alternative treatment to thousands of US patients diagnosed with leukaemia and other cancers who do not currently have the option of an oral liquid.”