MHRA approves the first generic raltegravir medicines to treat adult and paediatric patients infected by HIV
The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 19 July 2024, approved the first generic raltegravir medicines to treat adult and paediatric HIV patients who weigh at least 40kg.
The Human Immunodeficiency Virus (HIV) causes Acquired Immune Deficiency Syndrome (AIDS). HIV produces an enzyme called HIV integrase which enables multiplication of the virus in cells within the body.
Raltegravir stops this enzyme from working, and when used with other medicines it may reduce the amount of HIV in the patient’s blood and increase the patient’s CD4-cell count (a type of white blood cell that plays an important role in maintaining a healthy immune system). Reducing the amount of HIV in the blood may improve the functioning of the immune system, meaning the body may fight infection better.
The active ingredient raltegravir is an antiviral medicine prescribed as a 600 mg film‑coated tablet. The recommended dosage for the medicine is 1,200 mg as two 600 mg tablets taken orally once a day. Raltegravir must be used in combination with other medicines for HIV.
Shirley Hopper, MHRA Deputy Director of Innovative Medicines, said:
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 MHRA’s approval of the medicine is supported by evidence from studies in healthy volunteers. Studies have been limited to tests to determine that it is bioequivalent to the reference medicine. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. As raltegravir generics have been shown to be bioequivalent to the reference medicine, their benefits and possible side effects are considered to be the same as the reference medicine.
As with any medicine, the MHRA will keep the safety and effectiveness of raltegravir under close review. A full list of all side effects reported with raltegravir are available in the patient information leaflet or from the product information published on the MHRA website. If a patient experiences any side effects, they should talk to their doctor, pharmacist, or nurse. This includes any possible side effects not listed in the product information leaflets.
Anyone who suspects they are having a side effect from this medicine is encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA’s Yellow Card scheme.
ENDS
Notes to editors
- The new marketing authorisation was granted on 19 July 2024 to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited
- More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.
- The MHRA is an executive agency of the Department of Health and Social Care.
- For media enquiries, please contact the [email protected], or call on 020 3080 7651.