Merck’s last-resort antibiotic Recarbrio nears EU approval

Merck & Co/MSD’s three-drug antibiotic Recarbrio has been recommended for approval in Europe for Gram-negative infections, but should be reserved for use in patients with limited treatment options.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) backed approval of Recarbrio at its meeting last week, a few months after the drug was approved by the FDA for complicated urinary tract and intra-abdominal infections (cIAI).

The new drug combines the active ingredients in MSD’s broad-spectrum antibiotic Primaxin (imipenem/cilastatin) with a new beta lactamase inhibitor called relebactam that is designed to restore susceptibility to imipenem in resistant strains.

Drugs in the carbapenem class like imipenem have become last-line treatments for a number of multidrug resistant (MDR) infections, so Recarbrio could offer a fallback option in people with serious infections.

The CHMP notes that Recarbrio should only be prescribed “after consultation with a physician with appropriate experience in the management of infectious diseases” and with consideration to “official guidance on the appropriate use of antibacterial agents.”

The drug targets Gram-negative pathogens like Enterobacter cloacea, Escherichia coli, Klebsiella aerogenes, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Recarbrio’s reserved status means that it won’t be a big seller for MSD, with Cowen & Co analysts expecting sales to reach around $150 million in 2024, but it will be an important new option for patients.

The low returns on new antibiotic research have driven a lot of the multinational drugmakers out of the category, raising fears that MDR will become rampant and society could enter a post-antibiotic age where once-trivial infections can be life-threatening.

That disincentive is one of the factors behind a new UK proposal for a new payment system for antibiotics that will see companies paid upfront for access to new antibiotics based on their value to the NHS, rather than the volume of medicines sold.

Recarbrio was one of five new medicines recommended for approval by the CHMP at its latest meeting, along with Novartis’ wet age-related macular degeneration (AMD) therapy Beovu, Accord Healthcare’s generic versions of azacitidine for blood cancers and sedative dexmedetomidine, and Pfizer’s Amsparity – a biosimilar of AbbVie’s immunology blockbuster Humira (adalimumab).

There were also several new positive opinions on already-marketed drugs, including:

Janssen-Cilag’s Darzalex (daratumumab) for use in combination with Takeda’s Velcade (bortezomib), thalidomide and dexamethasone for adult patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant;
A new 61 mg soft capsule formulation of Pfizer’s Vyndaqel (tafamidis) for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with transthyretin amyloid cardiomyopathy (ATTR-CM);
Extending the age-range for children with plaque psoriasis eligible for treatment with Janssen-Cilag’s Stelara (ustekinumab) to six years and over from 12 and over;
Extending the age range for treatment with Janssen-Cilag’s pulmonary multidrug‑resistant tuberculosis (MDR‑TB) therapy Sirturo (bedaquiline) to include adolescents aged over 12 as well as adults;
New oral and intravenous infusion formulations of Helsinn Birex Pharma’s Akynzeo (fosnetupitant/palonosetron) for prevention of chemotherapy-induced nausea and vomiting (CINV);
Eli Lilly’s Cyramza (ramucirumab) in combination with Roche’s Tarceva (erlotinib) for the first-line treatment of adult patients with metastatic non-small cell lung cancer with activating EGFR mutations;
A new film-coated formulation of Astellas’ Dificlir (fidaxomicin) that extends the use of the Clostridioides difficile infection (CDI) drug to include children weighing over 12.5 kg as well as adults.