India-Made HIV Prevention Shot Gets FDA Nod

INDIA-MADE GENERIC HIV PREVENTION SHOT RECEIVES FDA APPROVAL

WHY IN THE NEWS ?

  • FDA Approval: The US Food and Drug Administration (FDA) has granted tentative approval to an India-made generic version of Lenacapavir, a twice-yearly injectable drug for HIV prevention.
  • Global Access: Developed by Dr. Reddy’s Laboratories, it aims to make HIV prevention affordable across 120 low- and middle-income countries.

India-Made HIV Prevention Shot Gets FDA Nod

KEY FEATURES OF GENERIC LENACAPAVIR:

  • Drug Profile: Lenacapavir is a long-acting injectable medicine used as Pre-Exposure Prophylaxis (PrEP) to prevent HIV infection among individuals at risk.
  • Administration: Unlike conventional preventive pills taken daily, this injection is administered twice a year, improving convenience and treatment adherence.
  • Indian Contribution: The generic version has been developed by Dr. Reddy’s Laboratories through an agreement facilitated by Unitaid, Clinton Health Access Initiative (CHAI) and Wits RHI.
  • Global Availability: The generic drug is expected to reach people in 120 low- and middle-income countries, subject to their respective regulatory approvals.
  • Affordable Pricing: The expected cost is approximately US$40 per person annually, making it comparable to existing daily preventive pills.

SIGNIFICANCE AND GLOBAL HEALTH IMPLICATIONS

  • HIV Prevention: Two groundbreaking clinical studies demonstrated that Lenacapavir could nearly eliminate new HIV infections among high-risk populations.
  • Improved Adherence: Twice-yearly administration reduces dependence on daily medication, addressing the problem of missed doses and inconsistent treatment.
  • Economic Accessibility: Affordable generic production can significantly reduce financial barriers and expand access to preventive healthcare in developing countries.
  • Epidemic Control: According to WHO figures cited in the report, approximately 41 million people were living with HIV worldwide, while around 570,000 deaths occurred due to HIV-related causes in the previous year.
  • Patent Restrictions: The generic version cannot be sold in the US because Gilead Sciences’ branded version, Yeztugo, remains patent-protected. Its US list price is approximately US$28,218 annually.

ABOUT HIV/AIDS AND PRE-EXPOSURE PROPHYLAXIS :

●      HIV Definition: Human Immunodeficiency Virus (HIV) attacks the immune system, particularly CD4 cells, weakening the body’s ability to fight infections.

●      AIDS: Acquired Immunodeficiency Syndrome (AIDS) is the most advanced stage of HIV infection.

●      Transmission: HIV spreads through infected blood, sexual contact, sharing contaminated needles and from mother to child.

●      PrEP Concept: Pre-Exposure Prophylaxis involves taking preventive medicines before potential exposure to HIV to reduce the risk of infection.

●      WHO Role: The World Health Organization (WHO) provides global guidelines, technical support and public health strategies to prevent and control HIV/AIDS.