PhD | Director Therapeutic Innovation and BaseLaunch
Tel. +41 61 295 50 17stephan. emmerth@baselarea. swiss
The Allschwil-based pharma company Polyphor has developed an innovative antibiotic in the form of murepavadin. The US authorization authority has now extended the approval range of this drug by four new indications.
The US Food and Drug Administration (FDA) has designated murepavadin, an innovative drug candidate developed by Polyphor, for inclusion in an approval process for four new indications, as announced in a press release from the Basel-based pharma firm. The drug is to receive the status of Qualified Infectious Disease Product (QIDP) for hospital-acquired bacterial pneumonia, acute bacterial skin and skin structure infections, bloodstream infections and complicated intra-abdominal infections. Up to now, it had been awarded this status for respiratory-associated bacterial pneumonia.
This status entails a whole host of advantages. Applications for approval are processed more rapidly, particularly in the relevant indications. Additionally, a five-year extension of market exclusivity will be granted upon approval of the first QIDP indication. Giacomo Di Nepi, CEO of Polyphor, commented in the press release: “These additional QIDP designations highlight the importance of our research in this area and recognize the innovativeness of our Outer Membrane Protein Targeting Antibiotic (OMPTA) program.” Moreover, incentives are created with regard to the further development of murepavadin in terms of additional indications.
Murepavadin is Polyphor‘s first product candidate on the basis of the OMPTA program to be transferred into the clinical development phase. It is currently subject to a Phase III study. Polyphor has announced that this is the first Phase III study for a new class of antibiotics to combat gram-negative bacteria for 50 years.