Approval for use of the new long-acting HIV prevention injection issued; What You Should Know
The long-acting HIV prevention injection has been officially approved in Kenya by the Ministry of Health following a thorough process of regulatory review
The long-acting HIV prevention injection has been officially approved in Kenya by the Ministry of Health following a thorough process of regulatory review.
The adoption is an important milestone in the fight to ensure that the country enhances HIV prevention measures and access to innovative medical technologies.
The Health Cabinet Secretary Aden Duale announced on a statement released on Saturday, January 10, that the Ministry, through the Pharmacy and Poisons Board (PPB), had approved the use of the new medicine in the country.
The generic name of the drug is Lenacapavir, which has been approved as a tablet and injectable to prevent HIV (PrEP) in pre-exposure prophylaxis. Duale states that the PPB has suggested the registration of the Lenacapavir 300 mg tablets and 464mg injectable solution as long-acting antiretroviral medicine, which is aimed at preventing HIV infection.
He made it clear that the approval was preceded by a rigorous scientific and regulatory review.
Duale said that the recommendation comes after a thorough review of the quality, safety, and efficacy of Lenacapavir, in compliance with the Kenyan regulations and the relevant international regulations.
He further explained that it was not an easy decision that came upon her and that it was made after serious consideration. The move by Kenya puts it at the forefront of the countries in Africa to give the drug a green light in terms of registration.
As Duale observed, the approval is in line with current world health recommendations, such as the World Health Organization (WHO) recommendations, and it reflects the increasing ability of Kenya to control and embrace new health technologies.
Kenya is one of the first African countries to exercise regulatory control over Lenacapavir.
This is an indication of the leadership role of the country in the area of public health and the desire to see to it that innovative prevention tools of public health significance are available at the right time, the statement said. Lenacapavir is a type of drug that interferes with the essential steps of the HIV lifecycle, making the virus unable to gain the right to be present in the body.
The long-acting formulation that enables it to be used only twice in a year is one of its main advantages. This is a big alternative to oral PrEP pills that need to be taken on a daily basis, especially by those who find it hard to take the pills daily.
Duale recognized that Kenya has been doing well in securing the availability of an oral daily dose of PrEP in all 47 counties; however, some users have difficulties with adherence. Reducing effectiveness may occur through factors like pill fatigue, stigma, and daily routine challenges.
He said that the challenges can be overcome through the use of long-acting injectable prevention options such as Lenacapavir, which has the potential to decrease the number of times a person needs to take the drug and to increase access to effective HIV prevention. The Cabinet Secretary announced that Kenya is also a top-priority country to roll out the first batch of Lenacapavir.
Pre-elaboration planning is already being undertaken so that the drug can be put into the market in a responsible, fair, and timely way, especially among those populations that are at high risk of being infected by HIV.
The announcement follows the fact that the Pharmacy and Poisons Board has made a public warning against the sale and distribution of unregistered, falsified, or counterfeit health products in Kenya.
The regulator, in a notice of December 9, warned manufacturers, importers, distributors, wholesalers, retailers, and supermarkets not to deal with such products. PPB also cautioned against all supermarkets, cosmetic stores, household goods stores, online sellers, and the rest of the general retail outlets from stocking or selling prescription-only medicines, as not only is the act of doing so illegal, but it can also be subject to regulatory measures.
According to the Board, the importation, possession, sale, or use of unregistered or counterfeit health products is illegal in the law and could lead to arrest. Those and groups detected to have violated this risk criminal liability, i.e., action against pharmacists, pharmaceutical technologists, pharmaceutical managers, pharmaceutical directors, and proprietors of the establishments that committed the violations. The measures that can be used in enforcement can be suspension or withdrawal of operating licences and closure of premises that are found to be in noncompliance.
PPB also encouraged companies to be cautious about the type of health products they can sell. When they are unsure of what they can sell, they should consult the Board.
The granting of Lenacapavir and the new regulatory alerts combine to highlight the government’s effort towards not only increasing access to life-saving drugs but also protecting the population against unsafe or illegal health products.
