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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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Body:In certain scenarios, in vitro dissolution tests can replace in vivo bioequivalence studies. This is particularly true when a drug product, though available in varying strengths, maintains proportional similarity in its active and inactive ingredients. In such cases, the need for in vivo bioequivalence studies for lower strength variants may be waived, provided dissolution tests and in vivo studies on the highest strength yield satisfactory results.Bioequivalence can be indicated through...
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Assays for the Identification of Novel Antivirals against Bluetongue Virus
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Bulevirtide: First Approval.

Connie Kang1, Yahiya Y Syed2

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

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|September 14, 2020
PubMed
Summary

Bulevirtide, a novel entry inhibitor, is now approved in the EU for chronic hepatitis delta virus (HDV) infection. This marks a significant advancement in treating HDV and HBV infections.

Area of Science:

  • Hepatology
  • Virology
  • Pharmacology

Background:

  • Chronic hepatitis delta virus (HDV) and hepatitis B virus (HBV) infections pose significant global health challenges.
  • Current treatment options for chronic HDV are limited, highlighting the need for novel therapeutic strategies.
  • Bulevirtide represents a first-in-class antiviral agent targeting viral entry.

Purpose of the Study:

  • To summarize the key developmental milestones of bulevirtide.
  • To highlight the regulatory pathway leading to its recent European Union approval.
  • To provide an overview of bulevirtide's role in treating chronic HDV infection.

Main Methods:

  • Review of preclinical and clinical development data for bulevirtide.
  • Analysis of regulatory submissions and approvals.

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  • Summary of efficacy and safety findings from pivotal studies.

    • Main Results:

    • Bulevirtide, a novel entry inhibitor, has demonstrated efficacy in treating chronic HDV infection.
    • The drug received European Union approval for adult patients with compensated liver disease and detectable HDV RNA.
    • Development milestones include successful clinical trials and regulatory submissions.

    Conclusions:

    • Bulevirtide's approval signifies a major therapeutic breakthrough for chronic HDV infection.
    • This milestone paves the way for improved management of co-infections with HBV.
    • Further research may explore bulevirtide's potential in broader patient populations and HBV treatment.