WHO Welcomes Signing of Sublicences with 3 Manufacturers to Produce Long-acting Injectable Cabotegravir for HIV Prevention

long-acting injectable cabotegravir

WHO is pleased to report that three manufacturers have signed licensing agreements with the Medicines Patent Pool (MPP) to develop long-acting injectable cabotegravir as pre-exposure prophylaxis (PrEP). This comes after the voluntary licensing deal reached in July 2022 between MPP and ViiV Healthcare, the maker of CAB-original LA’s formulation. With their subsidiary Mylan, the producers Aurobindo, Cipla, and Viartris will be able to create generic versions of long-acting injectable cabotegravir thanks to these sublicenses.

WHO suggested that long-acting injectable cabotegravir be made available as a supplementary prevention option in 2022 for those who are at high risk of contracting HIV. The long-acting injectable cabotegravir guidelines are based on a public health strategy that takes effectiveness, acceptability, feasibility, and resource demands across a variety of contexts into account, which is consistent with earlier WHO guidelines.

In two significant randomized controlled trials, long-acting injectable cabotegravir was found to be both extremely safe and highly effective among cisgender women, cisgender men who have sex with men, and transgender women who have intercourse with men. The results of a systematic review, which revealed thatlong-acting injectable cabotegravir is an acceptable HIV prevention option across various demographics, were also taken into account by the WHO when making their recommendation.

According to Dr. Meg Doherty, Director of WHO’s Global HIV, Hepatitis and STIs Programmes, “The signing of the sublicences with 3 manufacturers has the potential to enable major scale-up and deployment of long-acting injectable cabotegravir for HIV prevention in a large number of countries in the long term.”

To ensure country readiness when supply improves, WHO advises the current limited product to concentrate on CAB-LA implementation studies integrated into HIV programs.
Since the WHO recommendation, a sizable number of implementation science studies have been planned to address important unresolved research and implementation issues regarding long-acting injectable cabotegravir, including how people select and switch between PrEP products, how HIV drug resistance relates to HIV testing, how safe it is to become pregnant and breastfeed, service delivery models, and resource requirements.

In particular, people from key populations who, along with their sexual partners, account for 70% of all new HIV infections globally, according to UNAIDS estimates, are disproportionately affected by HIV even in generalized epidemics, and frequently face barriers to accessing effective HIV prevention options, should be taken into account in these projects.

WHO will continue to support and collaborate with implementation projects, nations as they consider regulatory approval and national guidelines, and manufacturers as part of the Coalition to Accelerate Access to Long-Acting PrEP, which was established with the help of the Global Fund, PEPFAR, UNAIDS, and Unitaid. AVAC served as the coalition’s secretariat. Cooperation between partners is essential to ensuring that research questions may be answered quickly and effectively.

Mor About Long-acting Injectable Cabotegravir

Cabotegravir is an FDA-approved prescription medication available in two different forms and under two different brand names: Cabotegravir oral tablet (also known as Vocabria) and Long-acting injectable cabotegravir (also known as Apretude). Long-acting injectable cabotegravir has demonstrated high efficacy in preventing HIV infections and has generated significant interest from various countries and communities as a potential additional prevention option for individuals at a high risk of contracting HIV. In December 2021, the FDA approved the use of CAB-LA in the United States.

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