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New Medicines

Tenkasi (UK/EU) Orbactiv (US) Acute bacterial skin and skin structure infections (ABSSSI) in adults

Information

Tenkasi (UK/EU) Orbactiv (US)
New molecular entity
Menarini
The Medicines Company

Development and Regulatory status

Launched
Licensed but not launched
Launched
April 2022
Apr 22Oritavancin is available in the UK. Price for 400mg powder for concentrate for solution for infusion in vial, 3=£1500.00 [25]
Jan 22UK launch is still planned [24].
Jul 19Company intends to launch in the UK in 2020 [22].
Oct 18Melinta Therapeutics enters into an agreement with Menarini Group under the terms of which, the latter acquired the exclusive co-development and commercialisation rights for Orbactiv in Europe [23].
May 18Orbactiv has been divested to Melinta [22].
Jan 18The Medicines Company are not able to share their plans for launch in the EU at this time [21].
Jan 18Oritavancin was launched in the US in Oct 14 [20].
Nov 17The Medicines Company has entered into an agreement to sell its antibiotics, Vabomere, Orbactiv and Minocin IV, to Melinta Therapeutics Inc. The transaction is expected to close Q1 2018 [19].
Apr 15The Medicines Company has not yet decided on a date for UK launch [18].
Mar 15The Medicines Company is seeking potential partners to support supply of oritavancin during 2015 and beyond [17].
Mar 15Approved in the EU. The marketing authorisation is valid in the 31 countries of the European Economic Area, which includes all 28 EU Member States, plus Norway, Iceland and Liechtenstein [17].
Mar 15UK launch plans uncertain.
Jan 15EU positive opinion for treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults [16].
Aug 14Approved by US FDA [15].
Feb 14Marketing application accepted by EMA in EU for cSSTI caused by susceptible gram-positive bacteria, including by MRSA, administered as a single dose [12].
Feb 14Filed in US for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose. In Dec 2013, the FDA designated oritavancin a Qualified Infectious Disease Product (QIDP), providing oritavancin priority review. A decision on approval is expected by 6 Aug 14 [11].
Nov 10SOLO-1 and SOLO-2 trials to evaluate a single-dose oritavancin vs. 7-10 days vancomycin for acute bacterial skin and skin structure infection are to begin following discussions with FDA and EMEA about their suitability for regulatory submissions [7].
Aug 09EU filing withdrawn as EMEA has indicated that it would need additional data before considering approval. The company are in discussion with the EMEA and FDA about the desigin if a new PIII study to start later this year
Dec 08Complete response letter from FDA stating that oritavancin cannot be approved at this time to treat cSSSI. An additional study has been requested to include subjects with MRSA [6].
Jun 08EU MAA filed June 08, for the therapy of complicated skin and soft tissue infections (cSSTI) caused by gram-positive bacteria MRSA [4].
May 08US marketing planned for 1H09. EU filing for the treatment of complicated skin and soft tissue infections is expected mid-2008 [3].
Feb 08Filed in US Feb 08 [2].
Dec 04Plan to file in US end 2004 [1].

Category

Glycopeptide
Skin and soft tissue infections (SSTIs) are common, and complicated SSTIs (cSSTIs) are the more extreme end of this clinical spectrum, encompassing a range of clinical presentations such as deep-seated infection, a requirement for surgical intervention, the presence of systemic signs of sepsis, etc. The vast majority of SSTIs are caused by S. aureus and β-haemolytic streptococci, usually Lancefield groups A, C and G, with group B occurring in diabetics and the elderly [13].
Acute bacterial skin and skin structure infections (ABSSSI) in adults
Intravenous

Trial or other data

Jul 13In SOLO II, all prespecified primary and secondary efficacy endpoints were met. Oritavancin was non-inferior to vancomycin for both US and European regulators´ required efficacy endpoints. All prespecified endpoints were achieved, both for the Early Clinical Evaluation (ECE) (or 48-72 hour) required by the FDA and for the later Post Therapy Evaluation (PTE) (7-14 days after end of treatment) required by the EMA. Adverse events were reported with similar frequencies on oritavancin and vancomycin [10].
Dec 12Results for SOLO-1 P3 study. All primary and secondary endpoints were met. Oritavancin was non-inferior to vancomycin for early clinical evaluation (48-72 hrs) and later endpoint (7-14 days after end of treatment). For the early clinical endpoint of cessation of spread, absence of fever and no rescue antibiotics, results were: Oritavancin, 82.3% vs. vancomycin, 78.9%. For those with confirmed MRSA infections, results for the same endpoint were oritavancin 80.8% vs. vancomyinc 80%. For the endpoint of investigator-assessed clinical cure, results were oritavancin 79.6% vs. vancomycin 80% [9].
Dec 10SOLO-1 (TMC-ORI10-01; NCT01252719) & SOLO-2 (TMC-ORI10-02) began recruitment to evaluate the efficacy & safety of single-dose oritavancin vs. multiple doses of vancomycin in the treatment of cSSSIs. Each trial will aim to enroll approximately 1,000 pts and will have as primary endpoint, a composite of resolution of fever & cessation of spread of visible infection without using rescue antibiotics at 48-72 hours following initiation of treatment. These trials will be conducted under a Special Protocol Assessment of the US FDA [8].
Dec 08The complete response letter from the FDA discusses several safety findings from two studies for cSSSI, including the high drop out rate of because of a lack of efficacy. The agency also points to the number of oritavancin-treated patients who died or had a serious adverse event such as sepsis or septic shock [6].
Sep 08PII trial results - 300 pts with complicated skin and skin structure infections - oritavancin taken in a single or an infrequent dosing regimen showed comparable efficacy and safety to a 3-7 day course of oritavancin treatment, as administered in 2 previous PIII trials for cSSSI [5].
SOLO-1 published in NEJM. All 3 efficacy endpoints (cessation spread/decrease lesion size/absence fever/no need for rescue antibiotic) met prespecified 10% noninferiority margin for stat IV dose oritavancin (n=475) vs. 7-10 days IV vancomycin (n=479); 82.3% vs. 78.9% (95% CI difference, −1.6 to 8.4%) [14].

Evidence based evaluations