FDA gives the nod to TMC's antiplatelet drug

The Medicines Company (TMC) has finally won US approval for its injectable antiplatelet drug Kengreal for the prevention of blood clots during heart procedures.

Kengreal (cangrelor) has been approved by the FDA for adult patients undergoing percutaneous coronary intervention (PCI) to open a blocked or narrowed coronary artery, three months after being given a green light in Europe as Kengrexal.

The FDA notes PCI using a procedure known as balloon angioplasty - often followed by the implantation of a metal stent to hold the vessel open - is carried out in about 500,000 people in the US every year.

TMC's efforts to bring cangrelor to market date back to 2006 and it has had a difficult regulatory ride, with the US regulator rejecting it last year with a request for more data. The company now says it plans to launch the product in July.

The drug is an intravenously-administered P2Y12 inhibitor - in the same class as AstraZeneca's Brilinta (ticagrelor) and Daiichi Sankyo/Eli Lilly's Effient (prasugrel) - and like its peers is moving into a market formerly dominated by Sanofi's Plavix (clopidogrel) which lost patent protection in 2012.

It has been approved for use in patients who cannot take an oral P2Y12 inhibitor and in those for whom treatment with a thrombolytic agent such as the glycoprotein IIb/IIIa receptor antagonists abciximab or eptifibatide is not suitable, a narrower indication than originally sought.

TMC's chef executive Clive Meanwell said recently that the company believes cangrelor "should be a treatment of choice in patients who are not pre-treated with an oral P2Y12 inhibitor, and who need urgent and rapid onset with reversibility of platelet control."  

He also suggested that health economic data should support premium pricing for the product and that it would be applicable for use in 90% of PCI procedures in the US. Some analysts seem a little less convinced by its prospect, however, with RBC Capital Market's Adnan Butt predicting sales of $80m-$100m at peak in the US market.

In a trial that compared Kengreal to Plavix in more than 10,000 participants, TMC's significantly reduced the occurrence of heart attack, the need for further procedures to open the artery and stent thrombosis, said the FDA.

The overall occurrence of serious bleeding was low but more common with Kengreal than with clopidogrel, with one in every 170 Kengreal-treated patients experiencing a serious bleed versus one in 275 on Sanofi's drug.

The approval comes as TMC is facing uncertainty over the patent status of its biggest-selling drug - the anticoagulant Angiomax (bivalirudin) – that had sales of $166m last year but is being challenged in the US by Hospira. 

TMC settled patent litigation with Sun Pharma at the end of March via deal that means the Indian company can launch a generic in 2019, or sooner if other generics reach the market.