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Tirzepatide Approved by NMPA for Type II Diabetes

Views: 28     Author: Unibest Industrial     Publish Time: 2024-05-21      Origin: Site

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On May 21st, the Chinese National Medical Products Administration (NMPA) approved Tirzepatide (brand name Mounjaro), a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist developed by Lilly, for the improvement of glycemic control in adults with type 2 diabetes. 

Approval Screenshot of Tirzepatide from NMPA news

src: NMPA


Tirzepatide is a once-weekly injectable GIP and GLP-1 receptor agonist. GLP-1 and GIP are two naturally occurring incretins that regulate glucose and energy homeostasis. Studies suggest that when combined with a GLP-1 receptor agonist, GIP may lead to greater impacts on glycemic control and weight loss. 



Trials


For type 2 diabetes, Lilly initiated the large SURPASS clinical trial program consisting of 10 studies, including head-to-head comparisons of Mounjaro (5mg, 10mg, and 15mg) with semaglutide 1mg, insulin glargine, and insulin degludec. Across the SURPASS program, Mounjaro 5mg led to a mean HbA1c reduction of 1.8-2.1%, while the 10mg and 15mg doses reduced HbA1c by 1.7-2.4% on average. 


The approval in China was mainly based on the positive results from the SURPASS program and the SURPASS-AP-Combo phase 3 trial, which enrolled type 2 diabetes patients inadequately controlled on metformin alone. 98.3% participants were Asian (n=917), and 83.4% were Chinese (n=763). After 40 weeks, Mounjaro (5mg, 10mg, and 15mg) demonstrated non-inferiority to titrated insulin glargine in HbA1c reduction and weight loss. 


Tirzepatide T2D trials


Moreover, Tirzepatide achieved significant weight loss across four phase 3 studies (SURMOUNT-1, -2, -3, and -4) in individuals with and without diabetes. In SURMOUNT-1 with non-diabetic obese participants (mean weight 104.8kg, mean BMI 38kg/m2), once-weekly subcutaneous Tirzepatide 15mg led to ~8% weight loss at week 12 and up to ~16% at week 36. At week 72, mean weight loss was 22.5% (24kg) with Tirzepatide 5mg, 10mg, and 15mg. 

Tirzepatide weightloss trials


In SURMOUNT-2 with type 2 diabetes and obesity, Tirzepatide 10mg and 15mg led to 15.7% (15.6kg) and 13.4% (13.5kg) weight loss respectively at week 72, with 81.6% and 86.4% achieving ≥5% weight loss (vs 30.5% with placebo). Both SURMOUNT-3 (obesity without diabetes) and SURMOUNT-4 (weight loss maintenance) also met primary and key secondary endpoints. 



Tirzepatide at FDA


Index Route Brand Name Labeler Approval Date Dosage
1 SOLUTION;SUBCUTANEOUS ZEPBOUND ELI LILLY AND CO Mar 28, 2024 10MG/0.5ML (10MG/0.5ML)
2 SOLUTION;SUBCUTANEOUS ZEPBOUND (AUTOINJECTOR) ELI LILLY AND CO Nov 8, 2023 10MG/0.5ML (10MG/0.5ML)
3 SOLUTION;SUBCUTANEOUS MOUNJARO (AUTOINJECTOR) ELI LILLY AND CO May 13, 2022 10MG/0.5ML (10MG/0.5ML)
4 SOLUTION;SUBCUTANEOUS ZEPBOUND (AUTOINJECTOR) ELI LILLY AND CO Nov 8, 2023 2.5MG/0.5ML (2.5MG/0.5ML)
5 SOLUTION;SUBCUTANEOUS ZEPBOUND (AUTOINJECTOR) ELI LILLY AND CO Nov 8, 2023 15MG/0.5ML (15MG/0.5ML)
6 SOLUTION;SUBCUTANEOUS ZEPBOUND ELI LILLY AND CO Mar 28, 2024 15MG/0.5ML (15MG/0.5ML)
7 SOLUTION;SUBCUTANEOUS MOUNJARO (AUTOINJECTOR) ELI LILLY AND CO May 13, 2022 5MG/0.5ML (5MG/0.5ML)
8 SOLUTION;SUBCUTANEOUS MOUNJARO (AUTOINJECTOR) ELI LILLY AND CO May 13, 2022 2.5MG/0.5ML (2.5MG/0.5ML)
9 SOLUTION;SUBCUTANEOUS ZEPBOUND (AUTOINJECTOR) ELI LILLY AND CO Nov 8, 2023 5MG/0.5ML (5MG/0.5ML)
10 SOLUTION;SUBCUTANEOUS MOUNJARO (AUTOINJECTOR) ELI LILLY AND CO May 13, 2022 12.5MG/0.5ML (12.5MG/0.5ML)
11 SOLUTION;SUBCUTANEOUS ZEPBOUND ELI LILLY AND CO Mar 28, 2024 5MG/0.5ML (5MG/0.5ML)
12 SOLUTION;SUBCUTANEOUS MOUNJARO (AUTOINJECTOR) ELI LILLY AND CO May 13, 2022 15MG/0.5ML (15MG/0.5ML)
13 SOLUTION;SUBCUTANEOUS ZEPBOUND ELI LILLY AND CO Mar 28, 2024 2.5MG/0.5ML (2.5MG/0.5ML)
14 SOLUTION;SUBCUTANEOUS MOUNJARO ELI LILLY AND CO Jul 28, 2023 12.5MG/0.5ML (12.5MG/0.5ML)
15 SOLUTION;SUBCUTANEOUS ZEPBOUND (AUTOINJECTOR) ELI LILLY AND CO Nov 8, 2023 7.5MG/0.5ML (7.5MG/0.5ML)
16 SOLUTION;SUBCUTANEOUS MOUNJARO ELI LILLY AND CO Jul 28, 2023 15MG/0.5ML (15MG/0.5ML)
17 SOLUTION;SUBCUTANEOUS MOUNJARO ELI LILLY AND CO Jul 28, 2023 5MG/0.5ML (5MG/0.5ML)
18 SOLUTION;SUBCUTANEOUS MOUNJARO ELI LILLY AND CO Jul 28, 2023 7.5MG/0.5ML (7.5MG/0.5ML)
19 SOLUTION;SUBCUTANEOUS MOUNJARO (AUTOINJECTOR) ELI LILLY AND CO May 13, 2022 7.5MG/0.5ML (7.5MG/0.5ML)
20 SOLUTION;SUBCUTANEOUS MOUNJARO ELI LILLY AND CO Jul 28, 2023 10MG/0.5ML (10MG/0.5ML)
21 SOLUTION;SUBCUTANEOUS ZEPBOUND ELI LILLY AND CO Mar 28, 2024 12.5MG/0.5ML (12.5MG/0.5ML)
22 SOLUTION;SUBCUTANEOUS ZEPBOUND (AUTOINJECTOR) ELI LILLY AND CO Nov 8, 2023 12.5MG/0.5ML (12.5MG/0.5ML)
23 SOLUTION;SUBCUTANEOUS MOUNJARO ELI LILLY AND CO Jul 28, 2023 2.5MG/0.5ML (2.5MG/0.5ML)
24 SOLUTION;SUBCUTANEOUS ZEPBOUND ELI LILLY AND CO Mar 28, 2024 7.5MG/0.5ML (7.5MG/0.5ML)



In November 2023, the FDA approved Tirzepatide (brand Zepbound) for chronic weight management in adults with obesity (BMI ≥30kg/m2) or overweight (BMI ≥27kg/m2) with at least one weight-related comorbidity. The weight management indication in China is currently under review by the NMPA. Tirzepatide is currently protected by three patents.



Patent Number Submission Date Expiration Date Drug Substance Patent? Drug Product Patent?
9474780 Jun 9, 2022 Jan 5, 2036 Y Y
11357820 Jun 30, 2022 Jun 14, 2039
Y
11918623 Mar 28, 2024 Jun 14, 2039


Tirzepatide patent status



References


PHARMCUBE article