MHRA Grants Marketing Authorisation to Lupin & Zentiva’s Generic Raltegravir

MHRA Grants Marketing Authorisation to Lupin & Zentiva’s Generic Raltegravir

UK MHRA grants marketing authorisation to Lupin Healthcare & Zentiva Pharma’s generic raltegravir to treat adult and paediatric HIV patients

Overview

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has 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.

New authorization- The new marketing authorisation was granted on 19th July, 2024 to Lupin Healthcare (UK) Limited and Zentiva Pharma UK Limited.

Raltegravir Function

  • 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.   

Raltegravir: Recommended Doses

  • 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.

From Innovative Medicines

  • 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.

Behind Approval

  • 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.

Safety Review by MHRA

  • 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.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!