The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for the first generic raltegravir medicines, designed to treat adult and pediatric HIV patients weighing at least 40 kg. This approval marks a significant step forward in the availability of affordable HIV treatment options.The new marketing authorization for generic raltegravir was granted to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited. This approval opens up new opportunities for patients to access effective and affordable HIV treatment.

The Human Immunodeficiency Virus (HIV) causes Acquired Immune Deficiency Syndrome (AIDS) by producing an enzyme called HIV integrase, which facilitates the virus’s multiplication in the body’s cells. Raltegravir inhibits this enzyme, helping to reduce the amount of HIV in the blood and increasing the patient’s CD4-cell count, a crucial type of white blood cell that maintains a healthy immune system. By lowering the HIV load, raltegravir improves the immune system’s functionality, enabling the body to combat infections more effectively.

The active ingredient, raltegravir, is an antiviral medicine available as a 600 mg film-coated tablet. The recommended dosage is 1,200 mg, taken as two 600 mg tablets once daily. Raltegravir must be used in combination with other HIV medications to ensure its effectiveness.

Shirley Hopper, MHRA Deputy Director of Innovative Medicines, emphasized the agency’s commitment to ensuring timely access to generic medicines. She noted that the approval of raltegravir generics is based on comprehensive data confirming their bioequivalence to the licensed reference medicine, Isentress. Bioequivalence indicates that the generics produce the same levels of the active substance in the body as the reference medicine, ensuring similar benefits and side effects.

The MHRA’s approval is supported by studies conducted in healthy volunteers to determine bioequivalence. The agency will continue to monitor the safety and effectiveness of raltegravir closely.

Patients experiencing any side effects are encouraged to report them to their doctor, pharmacist, or nurse and through the MHRA’s Yellow Card scheme.

The approval of generic raltegravir by the MHRA is a significant development in the fight against HIV. Generic medications play a crucial role in increasing accessibility and affordability, which is essential for managing chronic conditions like HIV. By ensuring bioequivalence, the MHRA guarantees that these generics are just as effective as their branded counterparts, providing patients with reliable treatment options.

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