Sun Pharma gets CDSCO panel nod for Tetracosactide injection
New Delhi: Sun Pharmaceuticals has got a go-ahead from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for the manufacturing and marketing of Tetracosactide injection 250 mcg/ml (40 IU), which is a diagnostic agent used in the screening of patients presumed to have adrenocortical insufficiency.
This came after the drug maker, Sun Pharma, presented the Pharmacodynamics (PD) study report before the committee in accordance with the SEC's prior recommendation dated 16.12.2020.
Tetracosactide injection is a synthetic peptide, identical to the 24-amino acid segment at the N-terminal of adrenocorticotropic hormone (ACTH). ACTH (1-24), a segment similar in all species, contains the biological activity that stimulates the production of corticosteroids in the adrenal cortex.
Tetracosactide, also known as synacthen, tetracosactrin, and cosyntropin, is made up of the first 24 amino acids (out of a total of 39) of ACTH and maintains all of the parent peptide's functions. Tetracosactide is used in the ACTH stimulation test to measure adrenal gland function and it increases the production of corticosteroids like cortisol by the adrenal glands.
Tetracosactide is used in the ACTH stimulation test to identify adrenocortical insufficiency, which is particularly common in Addison's disease.
In normal conditions, ACTH is released from the pituitary gland at the base of the brain, which acts on the adrenal glands, stimulating the production of steroid hormones (glucocorticoids). If the adrenal glands are healthy, a single injection of tetracosactide results in a rise in blood cortisol concentrations in 30 minutes. If the adrenal glands appear not to be working, then a tetracosactide injection can be given to check whether the problem is due to diseased or damaged adrenals or due to lack of pituitary ACTH.
Last year, at the 68th SEC meeting for Endocrinology & Metabolism, dated 04.08.2020, Sun Pharmaceutical presented their proposal for a clinical trial (CT) and bioequivalence (BE) waiver before the committee for Tetracosactide injection BP 250mcg/ml.
The committee then suggested that a comparative pharmacodynamics (PD) study of their product compared with the innovator product be conducted in human subjects. Accordingly, the firm was directed to submit the study protocol for review by the committee.
As a response, the firm presented the protocol for the PD research to the committee at the next SEC meeting for Endocrinology & Metabolism on December 16, 2020. In response to the PD study protocol, the committee granted permission to conduct the PD study subject to the following conditions :
1. Study team should include M.D. Medicine/Anesthesiologist as PI/CO-PI.
2. Exclusion criteria needs to be redefined.
3. Since the firm is conducting PD studies only through the IV route, the results of the study may not be applicable for approval of the product for the IM route.
Now, proceeding further, at the 88th SEC meeting for Endocrinology & Metabolism held on 14.07.2021 & 15.07.2021, the CDSCO Committee extensively evaluated the pharmacodynamics (PD) research report for Tetracosactide injection BP 250mcg/ml submitted by the firm.