Type of information: Positive opinion for the granting of a Market Authorisation in the EU
Product name: Xerava®
Therapeutic area: Infectious diseases
- antibiotic. Eravacycline is a novel, fully-synthetic fluorocycline antibiotic being developed for the treatment of serious infections. Eravacycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, thus preventing the incorporation of amino acid residues into elongating peptide chains. It has demonstrated potent activity against multidrug-resistant (MDR) pathogens, including carbapenem-resistant enterobacteriaceae (CRE), Acinetobacter baumannii, and colistin-resistant bacteria carrying the mcr-1 gene.
Company: Tetraphase Pharmaceuticals (USA - MA)
Disease: complicated intra-abdominal infections
- • On July 26, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positiveopinion, recommending the granting of a marketing authorisation for Xerava®,intended for the treatment of complicated intra-abdominal infections in adults. The drug will be available as a 50-mg powder for concentrate for solution for infusion.
- The benefits with Xerava® are its ability to effectively treat complicated intra-abdominal infections. The most common side effects are nausea, vomiting and infusion site phlebitis.
- The CHMP opinion is based on a comprehensive data package from IGNITE1 and IGNITE4, which were part of the Company’s phase 3 Investigating Gram-negative Infections Treated with Eravacycline (IGNITE) program. In IGNITE1, twice-daily intravenous (IV) Xerava met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV ertapenem in 536 patients using a 10% non-inferiority margin. In IGNITE4, a second phase 3 clinical trial in patients with cIAI, twice-daily IV Xerava met the primary endpoint, demonstrating non-inferiority in clinical cure versus IV meropenem in 500 patients using a 12.5% non-inferiority margin. In both IGNITE1 and IGNITE4, Xerava was well-tolerated and achieved high cure rates in patients with Gram-negative pathogens, including resistant isolates.
- A New Drug Application (NDA) is currently under review by the FDA with an upcoming Prescription Drug User Fee Act (PDUFA) date in August. Everest Medicines submitted an Investigational New Drug application to China'sFood and Drug Administration in June to conduct a phase 3 clinical trial of eravacycline in cIAI in China.
- • On August 17, 2017, Tetraphase Pharmaceuticals announced that the Marketing Authorization Application (MAA) for IV eravacycline for the treatment of complicated intra-abdominal infections has been submitted and was validated by the European Medicines Agency. The MAA filing is based on data from the phase 3 IGNITE clinical trial in which eravacycline was well tolerated and demonstrated statistical non-inferiority to ertapenem using the primary endpoint of clinical response at the test-of-cure (TOC) visit. Tetraphase intends to submit a New Drug Application to the FDA in the first quarter of 2018.
Submission of marketing authorization application USA :
Submission of marketing authorization application UE: 2017-08-17
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
Favourable opinion UE: 2018-07-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: