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Shorla Oncology Secures FDA Approval for IMKELDI, the First Oral Liquid Imatinib Solution

NextEdge Admin

26 Nov 2024

2 min 37 sec

Shorla Oncology, a U.S.-Ireland specialty pharmaceutical company, announced FDA approval of IMKELDI, the first oral liquid form of imatinib for treating certain leukemias and cancers. IMKELDI, an advanced liquid formulation of imatinib, addresses critical needs in managing chronic myeloid leukemia (CML), acute lymphoblastic leukemia, myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), and gastrointestinal stromal tumors (GIST).

"IMKELDI provides a precise, patient-friendly alternative for those with swallowing difficulties or requiring tailored dosing," said Sharon Cunningham, CEO of Shorla. Oral solutions eliminate the need for compounding, ensuring accurate and consistent dosing, particularly for patients with unique needs. The innovation leverages Shorla's proprietary technology to enhance accessibility and improve patient adherence.

In 2024, an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD, and up to 6,000 with GIST in the U.S. Despite imatinib’s proven clinical benefits, challenges like difficulty swallowing tablets and adherence issues persist, highlighting the importance of patient-friendly formulations like IMKELDI.

"This marks our fourth FDA approval as we continue re-innovating oncology treatments to meet real-world needs," said Orlaith Ryan, CTO and co-founder of Shorla. "Our goal is to create options that prioritize patient comfort and treatment success." Chief Commercial Officer Rayna Herman added, "IMKELDI reinforces our commitment to delivering accessible, affordable solutions that improve lives."

Shorla remains dedicated to transforming oncology care with a growing portfolio of innovative products designed to put patients first.

IMKELDI, an oral solution of imatinib mesylate and tyrosine kinase inhibitor, is FDA-approved for treating specific leukemias, including acute lymphoblastic leukemia and chronic myeloid leukemia, and other cancers in adults and children aged one year and older.