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CHMP positive opinions for three hospital acute care products: Kengrexal, Orbactiv and Raplixa


The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) issued positive opinions recommending marketing authorization for three of its pipeline development candidates ( Kengrexal ( Cangrelor ), Orbactiv ( Oritavancin ), and Raplixa ( Sealant powder ).

Kengrexal is the first intravenous antiplatelet agent that provides immediate, consistent, and rapidly reversible P2Y12 inhibition; Orbactiv is the first single-dose antibiotic for treatment of acute bacterial skin and skin structure infections ( ABSSSIs ) caused by susceptible designated Gram-positive bacteria, including Methicillin-resistant Staphylococcus aureus ( MRSA ); and Raplixa is the first ready-to-use, biologically active, powdered fibrin sealant that provides hemostasis in a wide range of bleeding settings.

Cangrelor is an immediately bioavailable and quickly reversible intravenous small molecule antiplatelet agent to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing PCI.
The Marketing Authorization Application ( MAA ) submission for Kengrexal to the EMA was based on the results from the CHAMPION PHOENIX trial which provided the primary evidence of efficacy for the proposed PCI indication for Kengrexal.
The results of CHAMPION PHOENIX, an 11,145 patient phase 3 randomized, double-blind clinical trial comparing Kengrexal to oral Clopidogrel in patients undergoing PCI were reported in March 2013.
Data from the CHAMPION pooled population of over 25,000 PCI patients provide additional clinical support for safety.
Kengrexal is contraindicated in patients with active pathological bleeding; increased risk of bleeding because of impaired hemostasis and/or irreversible coagulation disorders; or any history of stroke or intracranial hemorrhage. Kengrexal is also contraindicated in patients with known hypersensitivity to Cangrelor or any component of the product. Kengrexal can increase the risk of bleeding.
In clinical trials, the most common adverse reaction in patients treated with Kengrexal was bleeding ( 17.5% ) and dyspnoea ( 1.3% ).

Orbactiv for injection received FDA approval in the U.S. in August 2014. Orbactiv is the first and only FDA-approved single-dose IV antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections ( ABSSSI ) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus ( including Methicillin-susceptible and Methicillin–resistant isolates ), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group ( includes Streptococcus anginosus, Streptococcus intermedius, and Streptococcus constellatus ), and Enterococcus faecalis ( Vancomycin-susceptible isolates only).
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 Oritavancin for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection ( 405 patients ).
These trials have demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only IV Oritavancin dose infusion, versus 7-to-10 days of twice-daily Vancomycin ( 1 g or 15 mg/kg ).
Orbactiv approval in the US was also based on the results of the SOLO I and SOLO II clinical trials.
Use of intravenous unfractionated Heparin sodium is contraindicated for 48 hours after Orbactiv administration because the activated partial thromboplastin time ( aPTT ) test results are expected to remain falsely elevated for approximately 48 hours after Orbactiv administration.
Co-administration of Orbactiv and Warfarin may result in higher exposure of Warfarin, which may increase the risk of bleeding. Use Orbactiv in patients on chronic Warfarin therapy only when the benefits can be expected to outweigh the risk of bleeding.
Orbactiv has been shown to artificially prolong aPTT for up to 48 hours, and may prolong PT and INR for up to 24 hours.
Hypersensitivity reactions have been reported with the use of antibacterial agents including Orbactiv.
Infusion-related reactions have been reported.
The most common adverse reactions ( greater than or equal to 3% ) in patients treated with Orbactiv were headache, nausea, vomiting, limb and subcutaneous abscesses, and diarrhea.

Raplixa ( sealant powder ) is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical product, which is an aid in hemostasis during surgery.
The Marketing Authorization Application ( MAA ) submission for Raplixa ( formerly known as Fibrocaps ) to the EMA was based on a pivotal Phase III clinical trial, FINISH-3. FINISH-3 is an international, randomized, single-blind, controlled trial that compared the efficacy and safety of Raplixa, a ready-to-use, dry-powder fibrin sealant containing human plasma-derived thrombin and fibrinogen with gelatin sponge, vs. gelatin sponge alone for use as a hemostat for surgical bleeding in four indications ( spinal, hepatic, vascular, soft tissue dissection ).
The Phase III trial, which studied a total of 719 patients, met all primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, vascular surgery and soft tissue dissection.
Raplixa should not be applied directly into the circulatory system. Intravascular application of Raplixa may result in life-threatening thromboembolic events. Do not use Raplixa for treatment of severe arterial bleeding.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma are employed for Raplixa, despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
Raplixa must not be used as a glue for the fixation of patches. Raplixa must not be used as a glue for intestines ( gastrointestinal anastomoses ).
Life threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer fibrin sealant / hemostatic products.
Spray application of Raplixa must not be used in endoscopic or laparoscopic procedures.
The most commonly reported adverse events ( more than 5%) in patients treated with Raplixa were nausea, constipation, post-operative pain, hypokalemia, pyrexia, and low blood pressure, with the majority considered mild in intensity. ( Xagena )

Source: The Medicines Company, 2015

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