Regulatory GSK's HIV prevention drug moves toward marketing approval in...

GSK’s HIV prevention drug moves toward marketing approval in Europe


GSK Plc announced on Monday that ViiV Healthcare, its subsidiary focused on HIV treatments, has received a favorable recommendation for marketing authorization from the European Medicines Agency’s human medicines committee for its innovative product, cabotegravir long-acting injectable and tablets.

Cabotegravir is made for the purpose of safer sex practices as pre-exposure prophylaxis (PrEP) to lower the risk of sexually-acquired HIV-1 infection in adults at high risk and teenagers weighing at least thirty-five kgs. This breakthrough therapy marks a significant advancement in HIV prevention, offering a promising alternative for those at risk.

The recommendation by the EMA’s Committee for Medicinal Products for Human Use (CHMP) was primarily based on compelling results from various studies. Studies have shown that there is higher effectiveness when cabotegravir is given at least six times per year, compared to the daily oral PrEP option in reducing the risk of HIV transmission. This endorsement by the CHMP highlights the potential of cabotegravir to make a substantial impact on HIV prevention efforts across Europe.

Until recently, PrEP was only available in pill form, and GSK’s cabotegravir represents a ground-breaking development as the first non-pill option in this field. This innovation not only provides an additional choice for individuals seeking HIV protection but also addresses potential issues with adherence to daily oral medications.

The product, branded as Apretude, has already received approvals in various countries. Its widespread acceptance in these regions is a testament to its efficacy and potential to transform HIV prevention strategies globally.

By offering an injectable and tablet-based PrEP option, GSK aims to empower healthcare providers and at-risk individuals with a more diverse toolkit to combat the spread of HIV. The long-acting nature of cabotegravir further enhances its appeal, as it reduces the burden of frequent dosing and promotes treatment adherence.

As the global fight against HIV continues, cabotegravir’s recommended marketing authorization represents a significant milestone in the ongoing efforts to combat this devastating virus. GSK’s commitment to advancing HIV research and treatment is evident in its dedication to developing innovative solutions to address unmet needs in this critical area of healthcare.

GSK’s ViiV Healthcare has received a positive recommendation from the EMA for cabotegravir long-acting injectables and tablets as a highly effective PrEP option. This breakthrough therapy has the potential to revolutionize HIV prevention strategies, offering a convenient, non-pill alternative for at-risk individuals. With approvals in several countries already secured, cabotegravir represents a crucial step forward in the global fight against HIV, and its impact on public health could be profound. As further developments and approvals unfold, this innovative product may play a pivotal role in reducing the incidence of HIV and enhancing the quality of life for countless individuals worldwide.

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