Regulators in the USA have fast-tracked Merck & Co’s antibiotic relebactam.
Specifically, the US Food and Drug Administration has designated relebactam (previously known as MK-7655), the company’s investigational beta-lactamase inhibitor, as a Qualified Infectious Disease Product (QIDP) with fast-track status. The speedy assessment applies to intravenous use of relebactam for complicated urinary tract and intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.
QIDP designation offers certain incentives for the development of new antibiotics, including a five-year extension of data exclusivity and priority review of the New Drug Application when filed.
Nicholas Kartsonis, head of infectious disease at Merck Research Laboratories, said “the lack of new medicines to fight drug-resistant infections is a growing public health concern”. He added that “we look forward to working with the FDA and other experts in infectious disease to study this medicine with the goal of bringing it to people suffering from potentially life-threatening resistant bacterial infections as quickly as possible”.
Relebactam is being evaluated in combination with imipenem/cilastatin in Phase II and in preclinical studies has demonstrated antibacterial activity against a broad range of Gram-negative and beta-lactam-resistant pathogens. Merck plans to initiate Phase III studies for the combo in 2015.
