Shilpa Medicare JV Gets USFDA Nod for IMKELDI to Treat Leukaemia and GIST

Shilpa Medicare Limited announced that its joint venture, Oncosol (a 50:50 partnership with Liqmeds Lifecare Limited, part of the Zydus group, and Koana Healthcare Limited, part of the Shilpa Medicare group), along with its partner Shorla Oncology, has received USFDA approval for IMKELDI (imatinib oral solution). This is the first liquid oral formulation of imatinib designed for treating specific cancers, including certain forms of leukaemia and gastrointestinal tumours.

Details of IMKELDI

IMKELDI offers an advanced liquid formulation that ensures precise dosing, addressing a significant challenge in cancer treatment. It is approved for use in managing chronic myeloid leukaemia (CML), acute lymphoblastic leukaemia (ALL), myelodysplastic syndrome/myeloproliferative disease (MDS/MPD), and gastrointestinal stromal tumours (GIST).

By helping to slow or prevent cancer growth, IMKELDI can be a more patient-friendly and accessible treatment option.

In the U.S., it is estimated that 9,280 new cases of CML, over 10,000 of MDS/MPD, and approximately 6,000 of GIST will be diagnosed in 2024. Despite imatinib’s proven clinical efficacy, adherence to treatment remains a challenge for many patients. IMKELDI’s liquid form aims to address this unmet need, offering a more convenient delivery system to improve patient outcomes and compliance.

On November 28, 2024, Shilpa Medicare share price opened at ₹902.00, touching the day’s high at ₹923.90, as of 9:50 AM on the NSE.

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