NEW DELHI: India’s drug regulator has approved Eli Lilly and Company’s diabetes and obesity drug Mounjaro in a KwikPen presentation, the pharmaceutical giant announced on Thursday.
The Central Drugs Standard Control Organisation (CDSCO) has granted marketing authorisation for Mounjaro (tirzepatide) in the KwikPen format in India. According to the company, it is a multi-dose, prescription-based, single-patient-use prefilled pen designed for once-weekly administration.
Each pen delivers four fixed doses of 0.6 mL and has been approved in six dosage strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg.
“Mounjaro (tirzepatide) is the first and only dual GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, indicated as an adjunct to diet and exercise for the treatment of type 2 diabetes and chronic weight management in adults with obesity (BMI ≥ 30) or overweight (BMI ≥ 27) with one weight-related comorbidity,” the company said in a statement.
The announcement comes just days after Novo Nordisk revealed the launch of its weight-loss product Wegovy, which is yet to be made available in India.
“The approval of Mounjaro KwikPen marks a step forward in the care of people living with type 2 diabetes and obesity, offering a convenient way for patients to take their medication,” said Winselow Tucker, President and General Manager, Lilly India.
“With this approval, all six dosage options for Mounjaro (tirzepatide) will soon be available in India, supporting a more personalised approach to treatment and allowing healthcare professionals to tailor care based on individual patient needs and clinical goals.”
India has around 101 million people living with diabetes, and nearly half of these adult patients are inadequately treated with suboptimal glycaemic control.
Obesity, a chronic, relapsing disease, is a major risk factor for diabetes and is linked to over 200 health complications, including hypertension, dyslipidaemia, coronary heart disease, and obstructive sleep apnoea.
As of 2023, adult obesity prevalence in India stood at around 6.5%, affecting nearly 100 million people.
Mounjaro is a single-molecule, once-weekly, prescription-only medicine that selectively binds to and activates both GIP and GLP-1 receptors, which are natural incretin hormones.
In a glucose-dependent manner, Mounjaro (tirzepatide) improves both first-phase and second-phase insulin secretion and reduces glucagon levels. It also improves insulin sensitivity and delays gastric emptying, the statement noted.
GIP and GLP-1 receptors are both expressed in important areas of the brain that regulate appetite.
Mounjaro (tirzepatide) reduces body weight and decreases fat mass by regulating appetite. Moreover, the medicine has been demonstrated to regulate lipid utilisation, the US-based pharmaceutical company said.
“Mounjaro (tirzepatide) has already had a tremendous impact on millions of people living with type 2 diabetes and obesity, respectively,” the company added.