Type of information: Product launch
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 in patients 18 years of age and older.
- • On October 11, 2018, Tetraphase Pharmaceuticals announced the U.S. commercial launch of Xerava™ (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). The wholesale acquisition cost (WAC) of Xerava™will be $175 per day of therapy to support the xompany’s strategy of having Xerava™ used for the empiric treatment of cIAI.
• On September 20, 2018, Tetraphase Pharmaceuticals announced that the European Commission has adopted the Decision granting marketing authorisation for Xerava™(eravacycline) for injection for the treatment of complicated intra-abdominal infections (cIAI) in adults in the European Union. The company announced that it remains on track to launch in Europe via a phased introduction, beginning with Germany and the UK, in early 2019.
- • On August 27, 2018, Tetraphase Pharmaceuticals announced that the FDA has granted approval of Xerava™ for the treatment of complicated intra-abdominal infections (cIAI). In clinical trials, Xerava™ was well-tolerated and achieved high clinical cure rates in patients with cIAI, demonstrating statistical non-inferiority to two widely used comparators – ertapenem and meropenem.
- • 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.
- • 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.
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:
US authorization: 2018-08-27
UE authorization: 2018-09-20
Favourable opinion UE: 2018-07-26
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: