Cipla Secures USFDA Nod for Nilotinib, Set for 2025-26 Launch

20 Feb 2025 , 11:46 PM

Cipla has got final approval from the USFDA for New Drug Application (NDA) for its Nilotinib Capsules 50 mg, 150 mg and 200 mg respectively. Nilotinib is an FDA approved drug used for the treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia (CML), which is a cancer of blood and bone marrow.

According to Cipla, the regulatory clearance serves as an important landmark in the Company’s journey, allowing it to expand the depth of its oncology portfolio and its foothold in the US market. Nilotinib is also long expected to be launched in the US in FY 25-26.

Aimed to provide an effective therapy specifically for the U. S. CML patients, this drug satisfies a major unmet medical need. Nilotinib is the trade name for the oral capsule formulation that is used under a healthcare provider’s supervision for leukemia treatment. Chronic Myeloid Leukemia (CML) is a hematological malignancy seen predominantly in adults, with the average age at diagnosis around 64 years old.

In 2025, the American Cancer Society estimates that there will be approximately 9,560 new diagnoses of CML in the U.S., and roughly 1,290 deaths.

Cipla’s Q3 FY24 Revenue growth was 7% YoY at ₹7073 Crore. Revenue was expected at ₹6,870.2 crore. Though on the operating front, EBITDA (Earnings Before Interest, Tax, Depreciation, and Amortization) was up 14% at ₹1,989 crore y-o-y. EBITDA margin expanded by 200 basis points, rising from 26% to 28%, reflecting strong operational efficiency and improved profitability.