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FDA Approved Drugs: Changes to Approved Drugs

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Repaglinide (Prandin) and Nateglinide (Starlix), known as glinides, are oral insulin secretagogues that stimulate insulin release from pancreatic β cells by closing the ATP-sensitive potassium channels (KATP channel). Repaglinide controls insulin release from pancreatic β cells by managing potassium efflux. It shares two binding sites with sulfonylureas and also has a unique site, indicating overlapping mechanisms of action. With a rapid onset and a 4-7 hour duration, it effectively...
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Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
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Dipeptidyl peptidase 4 (DPP-4) is a serine protease widely distributed in the body. It's involved in the inactivation of GLP-1 and GIP hormones, which are crucial for insulin regulation. DPP-4 inhibitors, such as sitagliptin (Januvia), saxagliptin (Onglyza), linagliptin (Tradjenta), alogliptin (Nesina), and vildagliptin (Galvus), help increase the proportion of active GLP-1, enhancing insulin secretion. These inhibitors work by competitively binding to DPP-4. This binding causes a...
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Incretins include glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), which stimulate insulin secretion post-meals. In type 2 diabetes, GIP's efficacy is reduced, making GLP-1 a viable drug target. GIP originates from preproGIP.
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α-glucosidase inhibitors, including acarbose (Precose), miglitol (Glyset), and voglibose (Voglib) (primarily available in Asia), are drugs that control blood sugar levels by delaying the digestion of starch and disaccharides. They achieve this by inhibiting α-glucosidase enzymes in the intestine, which slow the absorption of carbohydrates in the intestine, which in turn leads to a prolonged release of the glucoregulatory hormone GLP-1 from intestinal L-cells.
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Imeglimin Hydrochloride: First Approval.

Yvette N Lamb1

  • 1Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. dru@adis.com.

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|September 2, 2021
PubMed
Summary

Imeglimin is a new oral medication for type 2 diabetes, approved in Japan. It targets multiple aspects of diabetes pathology, offering a novel treatment approach.

Area of Science:

  • Pharmacology and Endocrinology
  • Diabetes Mellitus Therapeutics
  • Drug Development and Approval

Background:

  • Type 2 diabetes (T2D) is a global health challenge requiring novel therapeutic strategies.
  • Imeglimin represents a first-in-class 'glimin' agent with a unique glucose-lowering mechanism.
  • Existing treatments for T2D have limitations, necessitating the development of new drug classes.

Purpose of the Study:

  • To summarize the key developmental milestones of imeglimin.
  • To highlight the clinical and preclinical data supporting imeglimin's efficacy and safety.
  • To document the regulatory pathway leading to imeglimin's first approval in Japan.

Main Methods:

  • Review of preclinical studies investigating imeglimin's mechanism of action and efficacy.

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  • Analysis of data from the pivotal Phase III TIMES program in T2D patients.
  • Summary of regulatory submissions and approvals in Japan.

    • Main Results:

    • Imeglimin demonstrated significant glucose-lowering effects in preclinical models and clinical trials.
    • The TIMES program confirmed the efficacy and safety profile of imeglimin for T2D.
    • Positive data supported the New Drug Application in Japan.

    Conclusions:

    • Imeglimin's development journey culminated in its first regulatory approval for T2D in Japan.
    • This approval marks a significant advancement in T2D treatment options.
    • Imeglimin's novel mechanism offers a promising therapeutic avenue for managing type 2 diabetes.