US and Ireland-based speciality pharmaceutical company Shorla Oncology has received the US Food and Drug Administration (FDA) approval for Imkeldi (imatinib) oral solution.
Imkeldi is an oral liquid formulation of imatinib mesylate, a tyrosine kinase inhibitor, indicated for the treatment of certain forms of leukaemia and other cancers.
Shorla developed the drug using its novel technology, to provide enhanced dosing accuracy.
Shorla CEO Sharon Cunningham said: “We are thrilled to offer an oral solution option for patients with leukaemia and other cancers, a meaningful advancement for thousands in need.
“Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area.”
Imkeldi can help slow or prevent the growth of specific cancers, including chronic myeloid leukaemia (CML) and acute lymphoblastic leukaemia.
The drug also acts against myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), and gastrointestinal tumours (GIST).
Shorla co-founder and chief technical officer Orlaith Ryan said: “This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation.
“Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”
Shorla chief commercial officer Rayna Herman said: “At Shorla, every innovation is driven by our commitment to put patients first.
“IMKELDI is another step forward as we continue to expand our growing portfolio with products that prioritise accessibility and affordability.”
Earlier this year, Shorla received the US Food and Drug Administration (FDA) approval for Tepylute (SH-105) to treat breast and ovarian cancer.
