MHRA approves first generic raltegravir medicines to treat HIV in adults and children
23 Jul 2024
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Source: PMLiVE
The Medicines and Healthcare products Regulatory Agency (MHRA) has approved the first generic raltegravir medicines to treat human immunodeficiency virus (HIV) in adult and paediatric patients.
The marketing authorisations granted to Lupin Healthcare and Zentiva Pharma specifically apply to patients weighing at least 40kg.
The number of people living with a diagnosed HIV infection and accessing care in England rose from 91,368 in 2021 to 94,397 in 2022.
Merck & Co’s – known as MSD outside the US and Canada – Isentress (raltegravir) is an antiretroviral drug licensed for use in HIV patients.
Its active ingredient, raltegravir, stops the HIV integrase enzyme, which enables multiplication of the virus in cells within the body, from functioning. When used with other medicines, it can decrease the amount of HIV in patients’ blood and increase their CD4-cell count, which plays a vital role in maintaining a healthy immune system.
The recommended dosage for the medicine, which must be used in combination with other HIV drugs, is 1,200mg as two 600mg tablets taken orally once daily.
The MHRA’s decision on the raltegravir generics was supported by evidence from studies of healthy volunteers, which demonstrated that they were bioequivalent to Isentress, meaning their benefits and possible side effects are considered to be the same.
Shirley Hopper, MHRA deputy director of innovative medicines, said: “Ensuring timely access to generic medicines is a key priority for us.
“Appropriate data has been provided to assure us that these medicines are the same as, and considered interchangeable with an already licensed reference medicine…”
The approval comes just days after the MHRA approved AstraZeneca’s orally-administered AKT inhibitor, Truqap (capivasertib), to treat a subset of adults with advanced breast cancer.
Patients eligible for the therapy will have hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer with at least one PIK3CA, AKT1 or PTEN alteration and will not have responded to other anti-hormonal-based therapies.
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