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MSD launches antibiotic combo Recarbrio in UK

Therapeutic indicated to treat infections caused by Gram-negative bacteria

MSD (also known as Merck & Co) has launched its novel antibiotic combination Recarbrio in the UK.

Earlier this year, the European Commission approved Recarbrio (imipenem/cilastatin/relebactam) for the treatment of infections caused by aerobic Gram-negative organisms in adults with limited treatment options.

The regimen combines MSD’s imipenem/cilastin duo with a new beta lactamase inhibitor called relebactam that is designed to restore susceptibility to imipenem in resistant strains.

In a pivotal phase 3 trial of adult patients with infections caused by imipenem-nonsusceptible Gram-negative bacteria, Recarbrio was comparable to the combination of imipenem/cilastatin plus colistin: 71% and 70%, respectively.

Colistin is a drug which was first introduced in the 1950s that has been resurrected to help fight challenging Gram-negative infections. The result was particularly significant, given that colistin is often reserved as a ‘last-line’ therapeutic for Gram-negative infections, although the drug can have significant side-effects including kidney damage.

According to the World Health Organization (WHO), at least 700,000 people die each year worldwide because of drug-resistant infections.

Despite the urgent need for new therapeutics to tackle the growing incidence of antimicrobial resistance (AMR), few pharmaceutical companies are undertaking research in this area.

This is mainly due to the fact that when new antibiotics are launched, they are often held in reserve and used only to treat the most resistant infections.

Earlier this year, the International Federation of Pharmaceutical Manufacturers and Association (IFPMA) raised nearly $1bn to support clinical research into new antibiotics in a bid to tackle AMR.

The aptly named AMR Action Fund is aiming to bring two to four new antibiotics to patients by 2030. The launch of the fund resulted from a collaboration between 20 biopharmaceutical companies, including MSD, the European Investment Bank (EIB), Wellcome Trust and the WHO.

Last year, the UK launched a subscription-style payment model aimed at incentivising pharma and biotech companies to develop new drugs needed to tackle resistant infections.

The new subscription trial, led by the UK National Institute for Health and Care Excellence (NICE) and NHS England and Improvement will see pharmaceutical companies paid upfront for access to drugs based on their usefulness to the NHS.

“The world risks losing the most powerful tool in medicine: antibiotics. AMR is an urgent threat that, over time, could affect us all and have public health and economic consequences even greater than COVID-19, unless we act now,” said David Peacock, managing director of MSD in the UK and Ireland.

“Current reimbursement frameworks simply do not support the level of sustained R&D investment that is needed to tackle AMR. While the UK’s efforts to pilot a new subscription model of antibiotic reimbursement is a step in the right direction, its scope is limited, and it remains unclear if the overall level of funding attributed to this scheme will prove sufficient to incentivise much needed investment,” he added.

Article by
Lucy Parsons

18th November 2020

From: Regulatory

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