Submit CT data of Liraglutide pre-filled pen for type 2 DM: CDSCO Panel Tells Biocon Pharma

New Delhi: Citing that the approved indication for BIOLIDE synthetic Liraglutide 6mg/ml solution for injection in a pre-filled pen in UK-MHRA is for weight management, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined Biocon Pharma to submit more clinical trial data for the proposed indication for the treatment of type 2 diabetes mellitus along with immunogenicity data or submit Phase-III clinical trial protocol to CDSCO for further review by the committee.

This came after Biocon Pharma presented their proposal for a grant of permission to manufacture and market synthetic Liraglutide 6mg/ml solution for injection in a pre-filled pen (18mg/3mL Pre-filled Pen) indicated for the treatment of type 2 Diabetes Mellitus along with Bioequivalence study report and justification for waiver of Phase-III clinical trial before the committee.

Liraglutide is a GLP-1 analog used in the management of type 2 diabetes mellitus, prevention of cardiovascular complications associated with diabetes, and obesity.

Liraglutide is an acylated synthetic glucagon-like peptide-1 analog. Liraglutide is an agonist of the glucagon-like peptide-1 receptor which is coupled to adenylate cyclase. The increase in cyclic AMP stimulates the glucose-dependent release of insulin, inhibits the glucose-dependent release of glucagon, and slows gastric emptying to increase control of blood sugar.

The firm has informed that they have got the approval for BIOLIDE synthetic Liraglutide 6mg/ml solution for injection in a pre-filled pen in the United Kingdom on April 12/2024 and submitted an approved copy of SMPC which was issued by MHRA (Medicines and Healthcare products Regulatory Agency) along with approval letter for the following indication:

Adults: as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obesity), or • ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidemia or obstructive sleep apnoea.

Adolescents (≥12 years):

BIOLIDE injection can be used as an adjunct to healthy nutrition and increased physical activity for weight management in adolescent patients from the age of 12 years and above with:

• obesity (BMI corresponding to ≥30 kg/m2 for adults by international cut-off points)* and

• body weight above 60 kg.

At the recent SEC meeting for endocrinology and metabolism held on 11th July 2024, the expert panel reviewed the proposal for the manufacture and marketing of synthetic Liraglutide 6mg/ml solution for injection in a pre-filled pen (18mg/3mL Pre-filled Pen) indicated for the treatment of type 2 Diabetes Mellitus along with bioequivalence study report and justification for waiver of Phase-III clinical trial before the committee.

After detailed deliberation, the committee noted that the approved indication for BIOLIDE synthetic Liraglutide 6mg/ml solution for injection in a pre-filled pen in UK-MHRA is for weight management.

Furthermore, the expert panel mentioned, "The firm has proposed an indication for the treatment of type 2 Diabetes Mellitus."

Therefore, in line with the above observation, the committee opined that the firm should submit more clinical trial data for proposed indication along with immunogenicity data or submit Phase-III clinical trial protocol to CDSCO for further review by the committee.

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