Shilpa Medicare-Zydus JV gets USFDA nod for Imkeldi for certain forms of leukemia, other cancers

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-11-27 11:56 GMT   |   Update On 2024-11-27 11:56 GMT
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Karnataka: Shilpa Medicare's Joint Venture Oncosol (50:50 JV with Liqmeds Lifecare Limited, a Zydus group company and Koana Healthcare Limited, Shilpa Medicare group company) along with its partner Shorla Oncology has announced that the US Food and Drug Administration (USFDA) has approved IMKELDI (imatinib oral solution), a oral liquid form of imatinib to treat certain forms of leukemia and other cancers.

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IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy. IMKELDI can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST).
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 the proven clinical benefits of imatinib, patient adherence can be an issue, underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system.

“We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need,” said Sharon Cunningham, chief executive officer of Shorla. “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.”

“This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation,” said Orlaith Ryan, chief technical officer and co-founder of Shorla. “Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer.”

Rayna Herman, chief commercial officer of Shorla added, “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 prioritize accessibility and affordability.”

Shilpa Medicare Limited, headquartered at Raichur, Karnataka, India, is a vertically integrated, manufacturer and distributor of drugs to global markets; specializing in the Oncology therapeutic segment and introducing novel drugs.

Read also: Shilpa Medicare gets CDSCO panel nod to conduct Phase III clinical trials for Recombinant Human Albumin 20%


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