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Related Concept Videos

FDA Approved Drugs: Changes to Approved Drugs01:26

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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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The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
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Body:Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Belzutifan: First Approval.

Emma D Deeks1

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

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|October 6, 2021
PubMed
Summary
This summary is machine-generated.

Belzutifan is a new HIF-2α inhibitor approved for VHL-associated tumors. This oral therapy targets renal cell carcinoma, CNS haemangioblastomas, and pNET, offering a non-surgical treatment option.

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Area of Science:

  • Oncology
  • Pharmacology
  • Genetics

Background:

  • Von Hippel-Lindau (VHL) disease is a hereditary cancer syndrome associated with multiple tumor types.
  • Hypoxia-inducible factor (HIF)-2α plays a key role in the pathogenesis of VHL disease-associated tumors.
  • Current treatment options for VHL-associated tumors are limited, especially for those not requiring immediate surgery.

Purpose of the Study:

  • To summarize the development milestones of belzutifan, an oral HIF-2α inhibitor.
  • To highlight the first FDA approval of belzutifan for specific VHL disease-associated tumors.
  • To provide an overview of ongoing clinical studies for belzutifan in other indications.

Main Methods:

  • Review of preclinical and clinical development data for belzutifan.
  • Analysis of regulatory submission and approval process for belzutifan.
  • Summary of published and ongoing clinical trials involving belzutifan.

Main Results:

  • Belzutifan (Welireg™) received FDA approval in August 2021 for specific VHL-associated tumors (RCC, CNS haemangioblastomas, pNET) not requiring immediate surgery.
  • Belzutifan is an oral small molecule inhibitor targeting HIF-2α.
  • Ongoing studies are evaluating belzutifan in other cancers like clear cell renal cell carcinoma (ccRCC) and phaeochromocytoma/paraganglioma.

Conclusions:

  • Belzutifan represents a significant advancement in targeted therapy for VHL disease.
  • The approval of belzutifan provides a new therapeutic option for patients with specific VHL-associated tumors.
  • Further research will continue to explore the efficacy and safety of belzutifan in various oncological settings.