Shots:
- The US FDA has granted approval to the company’s Exblifep for the treatment of complicated urinary tract infections (incl. pyelonephritis) patients (18yrs. & above) along with a 5-yr. marketing exclusivity extension until 2032
- The approval was based on clinical data that showed the effectiveness of Exblifep against antimicrobial resistance in gram –ve bacteria, especially resistance mediated by both ESBL and AmpC and data from the P-III (ALLIUM) study which met the 1EP of non-inferiority and superiority with the drug vs piperacillin/tazobactam
- Shanghai Haini Pharmaceutical is the drug’s exclusive license holder across Greater China and Advanz Pharma in the EU region
Ref: Businesswire | Image: Allecra Therapeutics| Press Release
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