Zydus receives US-FDA approval for ZITUVIO™ to treat adult patients with type 2 diabetes mellitus

The company received final approval from the USFDA for its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg

Zydus Lifesciences Limited today announced that the U.S. Food and Drug Administration (FDA) approved its New Drug Application (NDA) for ZITUVIO™ (Sitagliptin) tablets, 25 mg, 50 mg, and 100 mg.

ZITUVIO™ contains active ingredient Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

The approval of ZITUVIO™ is based on research, development, regulatory and manufacturing work performed by Zydus teams. ZITUVIO™ has undergone quality testing for Nitrosamines and potential genotoxic impurities as per current USFDA standards. ZITUVIO™ is compliant with current USFDA standards of Nitrosamines in Sitagliptin containing products.

"The ZITUVIO™ approval builds on Zydus' long-term commitment to offer healthcare professionals a new affordable treatment option in connection with diabetes management," said Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited.

"We are pleased to be able to receive such a milestone approval for Zydus. Through our industry leading capabilities, we pride ourselves in finding innovative ways to bring value to the healthcare systems by providing affordable medicines for our patients. We look forward to bringing additional innovative products in the future that align with our purpose to empower patients to live healthier and more fulfilled lives," said Dr. Punit Patel, CEO of Zydus Pharmaceuticals, Americas.

According to IQVIA™ (MAT Aug-2023), U.S. market for DPP-IV inhibitors and its combinations is US$ 10 bn.

About Zydus

The Zydus Group with an overarching purpose of empowering people with freedom to live healthier and more fulfilled lives, is an innovative, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group employs 25000 people worldwide and is driven by its mission to unlock new possibilities in life sciences through quality healthcare solutions that impact lives. The group aspires to transform lives through pathbreaking discoveries.

INDICATIONS AND USAGE

ZITUVIO™ is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Limitations of Use:

• ZITUVIO™ is not recommended in patients with type 1 diabetes mellitus.
• ZITUVIO™ has not been studied in patients with a history of pancreatitis.
• DOSAGE AND ADMINISTRATION
• The recommended dosage of ZITUVIO™ is 100 mg orally once daily. ZITUVIO™ can be taken with or without food.
• Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m2.
• Dosage Adjustment in Patients with Renal Impairment
• eGFR greater than or equal to 30 mL/min/1.73 m² to less than 45 mL/min/1.73 m²
• eGFR less than 30 mL/min/1.73 m² (including patients with end stage renal disease [ESRD] on dialysis)
• 50 mg once daily
• 25 mg once daily
• DOSAGE FORMS AND STRENGTHS
• Tablets: 100 mg, 50 mg, and 25 mg
• CONTRAINDICATIONS
• History of a serious hypersensitivity reaction to Sitagliptin or any of the excipients in ZITUVIO™, such as anaphylaxis or angioedema
• WARNINGS AND PRECAUTIONS
• Pancreatitis: There have been post marketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue ZITUVIO™
• Heart failure: Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of ZITUVIO™ in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms.
• Acute Renal Failure: Has been reported post marketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating ZITUVIO™ and periodically thereafter.
• Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues: Increased risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required.
• Hypersensitivity Reactions: There have been post marketing reports of serious allergic and hypersensitivity reactions in patients treated with Sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop ZITUVIO™, assess for other potential causes, institute appropriate monitoring and treatment.
• Severe and Disabling Arthralgia: Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate.
• Bullous Pemphigoid: There have been post marketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue ZITUVIO™.

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