The Medicines Company's cangrelor leads trio of CHMP opinions
This article was originally published in Scrip
The Medicines Company is celebrating receiving three positive opinions from the EU's CHMP at its latest meeting this week, including for its antiplatelet agent Kengrexal (cangrelor), and its sealant powder Raplixa. Its antibiotic Orbactiv (oritavancin) was also one of two such products given marketing go-ahead by the committee (see scripintelligence.com, 23 January 2015).
The EU nod for the platelet aggregation inhibitor, Kengrexal, is reassuring for the company, as the drug was the subject of a US FDA complete response letter after the FDA's cardiovascular and renal drugs advisory panel voted against approval in February (scripintelligence.com, 1 May 2014). The US agency wants additional analyses of the company's CHAMPION PHOENIX study and other information, and has yet to approve the product, a direct P2Y12 platelet receptor inhibitor.
The proposed EU indication is for the reduction of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention (PCI) who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors is not feasible or desirable. Kengrexal should be co-administered with acetylsalicylic acid (aspirin).
Cangrelor blocks adenosine diphosphate (ADP)-induced platelet activation and aggregation in vitro and ex vivo. Cangrelor binds selectively and reversibly to the P2Y12 receptor to prevent further signalling and platelet activation.
The CHMP noted that its benefits were its ability to inhibit platelet aggregation and, co-administered with aspirin, prevent occurrence of thrombotic cardiovascular events in adult patients with coronary artery disease undergoing percutaneous coronary intervention and who have not received prior oral P2Y12 therapy.
The most common side effects with the drug are mild and moderate bleeding and dyspnoea. Serious adverse reactions associated with cangrelor in patients with coronary artery disease include severe/life threatening bleeding and hypersensitivity, the committee added.
The MAA submission based on the results from the CHAMPION PHOENIX trial, an 11,145 patient Phase III randomized, double-blind clinical trial comparing cangrelor to oral clopidogrel in patients undergoing PCI were reported in March 2013. Data from the CHAMPION pooled population of over 25,000 PCI patients provided additional clinical support for safety.
Raplixa
Meanwhile, the CHMP also gave the go-ahead for marketing of Raplixa (human fibrinogen/human thrombin, formerly Fibrocaps) 79 mg/g, 726 IU/g, sealant powder for use in controlling surgical bleeding.
The approved indication is: "Supportive treatment where standard surgical techniques are insufficient for improvement of haemostasis. Raplixa must be used in combination with an approved gelatin sponge. Raplixa is indicated in adults over 18 years of age." It is proposed that the use of Raplixa should be restricted to experienced surgeons.
The applicant was ProFibrix, a Dutch biotech company that was bought by The Medicines Company in 2013.
The Medicines Company says the product is a ready-to-use dry powder, fibrin sealant which may minimize the time required for preparation and potential wastage, and can be applied directly from the vial or with a spray device, providing much needed flexibility.
The CHMP said the benefit with Raplixa was its ability to reduce the time to haemostasis compared to using a gelatin sponge alone as seen in clinical studies in patients undergoing spinal, vascular, liver and soft tissue surgery where conventional surgical techniques such as suture, ligature and cautery were ineffective or impractical. The most common side effects are insomnia and pruritus, it added.
The product is also awaiting US approval with a PDUFA action date set for 31 January.