Polyphor's POL7080 receives QIDP designation from the FDA

Privately-held Swiss pharma firm Polyphor says that the US Food and Drug Administration has designated POL7080, its lead antibiotic product, as a Qualified Infectious Disease Product (QIDP) for the treatment of ventilator-associated bacterial pneumonia (VABP) caused by Pseudomonas aeruginosa.

A QIDP designation, granted under the US Generating Antibiotic Incentives Now (GAIN) Act, provides certain incentives for the development of new antibiotics including priority review, eligibility for fast-track status and a five-year extension of market exclusivity in the USA if the product is approved.

Antimicrobial resistance represents a major threat to public health worldwide. Pseudomonas aeruginosa accounts for 10% of hospital-acquired infections in the USA and is listed as one of the six most dangerous drug-resistant microbes. Surveillance programs revealed that over 15% of Pseudomonas aeruginosa isolates were resistant to at least three classes of antibiotics and close to 5% were resistant to all five classes.