The Medicines and Healthcare products Regulatory Agency (MHRA) has announced that its Yellow Card Biobank will begin investigating a new group of medicines to prevent strokes.

First launched in partnership with Genomics England in June 2023, the Yellow Card Biobank will help to improve understandings of how genetic makeup can impact the safety of medicines and to improve personalised medicine approaches.

Accumulated genetic data and patient samples will operate alongside the MHRA’s Yellow Card reporting site for suspected side effects and adverse drug reactions (ADRs), which involve medicines and medical devices.

In total, ADRs account for one in 16 hospital admissions in the UK and continue to be a significant burden on the NHS.

In its second phase, the genetic biobank will begin investigating direct oral anticoagulants, such as apixaban, dabigatran, edoxaban and rivaroxaban.

A stroke, responsible for more than 100,000 cases in the UK every year, occurs when the blood supply to parts of the brain is cut off.

Scientists will use the biobank to investigate whether specific genetic traits can cause side effects from a particular medicine, which will enable healthcare professionals to target prescriptions using rapid screening tests, allowing patients to receive the safest medication for them.

The MHRA has urged anyone who has experienced excessive bleeding following the use of direct oral anticoagulants to report it via its Yellow Card scheme.

This information will be used to explore whether some people are at a higher risk of excessive bleeding due to their genetic makeup and to reduce the occurrence of serious ADRs.

In spring 2024, sequencing of the patients’ genetic material will begin, with initial research findings from the pilot expected in 2025.

Dr June Raine, chief executive officer at the MHRA, said: “Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing” and “the Yellow Card Biobank will help us move towards our goal of personalised medicine”.

Professor Matt Brown, chief scientific officer at Genomics England, said: “We hope that through the Yellow Card Biobank pilot we will gain a deeper understanding of these genetic influences that, in turn, could help patients to receive the best and safest treatment possible."

https://www.pmlive.com/pharma_news/mhra_launches_second_phase_of_genetic_biobank_for_stroke_prevention_medicines_1508412