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Cempra Inc has completed its rolling submission of the New Drug Applications (NDA) for solithromycin to the US FDA for the treatment of community-acquired bacterial pneumonia (CABP). Based on the Qualified Infectious Disease Product (QIDP) designation by the FDA of solithromycin, Cempra has Priority Review and has been granted Fast Track for both the oral capsule and intravenous formulations for the treatment of CABP, which could result in an FDA decision on solithromycin’s NDA within eight months, or by the end of 2016, based on the Prescription Drug User Fee Act (PDUFA) performance goals. Solithromycin is a highly potent next-generation macrolide, the first fluoroketolide, which has potent activity against most macrolide-resistant strains. The FDA has a 60-day filing review period to determine whether the NDAs are complete and acceptable for filing, and to confirm that Priority Review has been granted.

The FDA has fast-tracked Cempra Inc’s solithromycin intravenous (IV) and capsules to treat community acquired bacterial pneumonia (CABP), according to a company news release. Solithromycin is currently in Phase 3 development for the treatment of CABP and submission of a New Drug Application (NDA) is planned for 2016, the company reported. The FDA’s Fast Track program was designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Additional clinical studies with solithromycin include a Phase 3 trial in uncomplicated gonorrhea that is expected to complete patient enrollment by the end of 2015, a Phase 2 trial in chronic obstructive pulmonary disease (COPD), a Phase 2 trial in nonalcoholic steatohepatitis (NASH), and a Phase 1b trial in pediatric patients.

Cempra expects to communicate the agency’s decision regarding acceptance of the NDAs and its PDUFA date when it is known.

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10.05.2015, author: admin
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