MHRA Approves First Generic Raltegravir for HIV Treatment

The Medicines and Healthcare products Regulatory Agency (MHRA) has given approval to the first generic versions of raltegravir for the treatment of HIV in both adult and paediatric patients. Specifically, these generic raltegravir medicines, produced by Lupin Healthcare and Zentiva Pharma, are authorized for use in patients who weigh at least 40 kilograms.

In England, the number of individuals diagnosed with HIV and receiving care has increased from 91,368 in 2021 to 94,397 in 2022. This rise underscores the importance of accessible and affordable treatment options.

Raltegravir, initially developed by Merck & Co. (known as MSD outside the US and Canada) under the brand name Isentress, is an antiretroviral medication used in HIV treatment. The drug works by inhibiting the HIV integrase enzyme, which is essential for the virus's replication within the body’s cells. When used in combination with other HIV medicines, raltegravir can reduce the viral load in patients' blood and boost their CD4-cell count, crucial for a robust immune system.

The recommended dosage for raltegravir is 1,200 mg, administered as two 600 mg tablets taken once daily. This regimen must be combined with other HIV treatments to be effective.

The MHRA's approval of the generic versions of raltegravir was based on studies involving healthy volunteers. These studies demonstrated that the generics are bioequivalent to Isentress, meaning they have the same therapeutic benefits and potential side effects.

Shirley Hopper, the MHRA's deputy director of innovative medicines, emphasized the significance of timely access to generic medicines. She stated that the provided data assured the agency that these generic versions are identical to and can be used interchangeably with the already licensed reference medicine.

This approval is part of a broader trend by the MHRA to expand access to necessary medications. Recently, the agency also approved AstraZeneca’s Truqap (capivasertib), an orally-administered AKT inhibitor for a subset of adults with advanced breast cancer. Eligible patients will have hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer with specific genetic alterations (PIK3CA, AKT1, or PTEN) and will not have responded to other anti-hormonal therapies.

Additionally, the UK regulator approved a subcutaneous formulation of Roche’s Ocrevus (ocrelizumab) for treating adults with relapsing and primary progressive multiple sclerosis. These approvals highlight the MHRA's commitment to facilitating access to innovative treatments for various serious health conditions.