Date: 2015-03-30
Type of information: Granting of a Market Authorisation in the EU
Product name: Orbactiv™
Compound: oritavancin
Therapeutic area: Infectious diseases
Action mechanism:
- antibiotic. Oritavancin is a semisynthetic lipoglycopeptide analogue of vancomycin that contains the heptapeptide core common to all glycopeptides. Oritavancin’s mechanism of action involves at least 3 known mechanisms: inhibition of transglycosylation, inhibition of transpeptidation, and cell membrane interaction/disruption. This antibiotic has been developed by Targanta Therapeutics. This company has been bought out by The Medicines Company in January 2009.
- In January 2018, The Medicines Company has closed the sale of its infectious disease business unit to Melinta Therapeutics.
- Orbactiv™ is approved in the United States and European Union for the treatment of adult patients with acute bacterial skin and skin structure infection (ABSSSI) caused by designated, susceptible gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
Company: Melinta Therapeutics (USA - CT)
Disease:
- acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA)
- complicated skin and skin tissue infections (cSSTI), caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus (MRSA)
Latest news:
- • On March 30, 2015, The Medicines Company announced that the European Commission has granted marketing authorization for Orbactiv™ (oritavancin). The marketing authorization is now valid in the 31 countries of the European Economic Area (EEA), which includes all 28 European Union (EU) Member States, plus Norway, Iceland and Liechtenstein. The Marketing Authorization Application (MAA) submission for Orbactiv™ to the EMA was based on the results of the SOLO I and SOLO II clinical trials which were randomized, double-blind, multi-center trials that evaluated a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only ORBACTIV IV dose, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg). Orbactiv™ approval in the US in August 2014 was also based on the results of the SOLO I and SOLO II clinical trials.
- • On 22 January 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Orbactiv®, 400 mg, powder for concentrate for solution for infusion, intended for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. The benefits with Orbactiv® are its ability to effectuate cure of ABSSSI with a single intravenous (IV) dose. In two identical designed pivotal trials (SOLO 1 and SOLO 2), oritavancin showed non-inferiority versus vancomycin comparator, for early clinical response (cessation of spread or reduction in size of the lesion) and clinical cure rates. The most common side effects are nausea, hypersensitivity reactions, infusion site reactions, and headache. A pharmacovigilance plan for Orbactiv® will be implemented as part of the marketing authorisation.
- • On August 6, 2014, The Medicines Company announced that the FDA has approved Orbactiv™ (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). Orbactiv™ is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over three hours, the Orbactiv™ treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens. Orbactiv™approval is based on the results of the SOLO I and SOLO II clinical studies which were randomized, double-blind, multicenter trials that evaluated a single 1200 mg IV dose of Orbactiv™ for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only IV Orbactiv™ dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).
- Orbactiv™ was designated as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies Orbactiv™ for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
- The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Orbactiv™, for which the company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission is expected during the first half of 2015.
- • On February 27, 2014, The Medicines Company has announced that the European Medicines Agency (EMA) has accepted for review a marketing authorization application (MAA) for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections (cSSTI), caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose. The oritavancin MAA is also based on data from Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients (modified intent-to-treat population, or mITT), with 405 of the patients suffering from a cSSTI with a documented MRSA infection.
- • On February 19, 2014, The Medicines Company has announced that the FDA has accepted the filing of a new drug application (NDA) for oritavancin with priority review. The Medicines Company is seeking approval of oritavancin 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. The oritavancin NDA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II, which were conducted under a Special Protocol Assessment (SPA) agreement with the FDA. These Phase 3 trials evaluated the efficacy and safety of a single 1200mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients (modified intent-to -treat population, or mITT), with 405 of the patients suffering from an ABSSSI with a documented MRSA infection.
- In December 2013, the FDA designated oritavancin as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides oritavancin priority review, and an additional five years of exclusivity upon approval of the product for the treatment of ABSSSI. Priority review means the FDA\'s goal is to take action on the application within six months, compared to 10 months under standard review. The FDA action date (PDUFA date) for oritavancin is August 6, 2014.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-08-06
UE authorization: 2015-03-30
Favourable opinion UE: 2015-01-22
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE:
OTC status:
Other news:
Is general: Yes
