MHRA Approves First Generic Raltegravir Medicines For HIV Treatment

The first generic raltegravir medications for treating adult and pediatric HIV patients weighing at least 40kg have been authorized by the UK Medicines and Healthcare products Regulatory Agency (MHRA). HIV is responsible for AIDS, which is a syndrome that weakens the body's immune system. HIV creates a protein called HIV integrase that allows the virus to replicate in cells in the body.

Both pharmaceutical firms Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited were granted a new marketing authorisation on July 19, 2024.

Raltegravir inhibits the enzyme's activity, potentially lowering HIV levels and boosting CD4-cell count when combined with other medications. Lowering HIV levels in the bloodstream could enhance immune system performance, enabling the body to combat infections more effectively.

Raltegravir, the active component, is a antiviral medication administered in the form of a 600 mg film-coated tablet. The prescribed amount of medicine is 1,200 mg to be taken orally once daily, in the form of two 600 mg tablets. Raltegravir should be administered alongside other medications for HIV treatment.

Shirley Hopper, MHRA deputy director of Innovative Medicines, added: “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.