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London, United Kingdom, July 19, 2024 /ChatnewsTV/ — The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first generic versions of raltegravir for adult and paediatric patients weighing at least 40kg. The approval, granted today, marks a critical step in enhancing access to affordable HIV medications.
The Human Immunodeficiency Virus (HIV) leads to Acquired Immune Deficiency Syndrome (AIDS) by producing an enzyme called HIV integrase, which facilitates the virus’s multiplication within the body. Raltegravir, an antiviral medicine, inhibits this enzyme’s activity. When used in combination with other medications, raltegravir can reduce the amount of HIV in the patient’s blood and increase the CD4-cell count, a type of white blood cell vital for maintaining a healthy immune system. This reduction improves the immune system’s ability to fight infections.
The active ingredient, raltegravir, is now available as a 600 mg film-coated tablet, with the recommended dosage being 1,200 mg, taken as two 600 mg tablets once daily. The medication must be used alongside other HIV treatments.
Shirley Hopper, MHRA Deputy Director of Innovative Medicines, emphasized the importance of this approval: “Ensuring timely access to generic medicines is a key priority for us. Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with, an already licensed reference medicine called Isentress. As with all products, we will keep the safety of raltegravir under close review.”
The approval of generic raltegravir is based on evidence from studies conducted on healthy volunteers. These studies were designed to confirm that the generic versions are bioequivalent to the reference medicine, Isentress, meaning they produce the same levels of the active substance in the body. Consequently, the benefits and potential side effects of the generics are expected to be the same as those of the reference medicine.
As with any medication, the MHRA will continuously monitor the safety and effectiveness of raltegravir. A comprehensive list of reported side effects can be found in the patient information leaflet or on the MHRA website. Patients are encouraged to report any side effects to their healthcare provider and the MHRA’s Yellow Card scheme.
The new marketing authorisation for generic raltegravir was granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited. Detailed information about the product, including the Summary of Product Characteristics and Patient Information leaflets, will be available on the MHRA Products website within seven days of approval.
