Amgen’s chronic heart failure (CHF) drug ivabradine has been granted priority review by the FDA to go along with fast-track status awarded in April, raising hopes of early entry into the US market.
The much-anticipated drug works as an inhibitor of the so-called ‘funny’ current in the pacemaker area of the heart, slowing down heart rate and lessening the strain on the weakened organ. While beta-blockers are already used to achieve heart rate reductions in CHF they have other unwanted effects, such as reducing the contractility and electrical conductance of the heart muscle.
This profile means ivabradine is widely-regarded as a potential game changer in CHF care. For example, when the drug was added to background CHF therapy in the 6,500-patient SHIFT trial it reduced heart rate by 10 per cent, reducing the risk of cardiovascular death and hospital admission for worsening symptoms by 18 per cent.
To put that in perspective, the observational Paris Prospective Study showed in 2009 that an increase of four beats per minute in resting heart rate was associated with a 19 per cent increase in all-cause mortality.
“The priority review designation by the FDA is evidence that CHF is a serious condition, which leads to high rates of rehospitalisation and poor prognosis despite available treatments,” said Amgen’s R&D head Sean Harper.
“If approved, ivabradine would potentially provide a significant improvement … for this grievous condition,” he added.
The priority review is good news for Amgen, as it indicates that the FDA may be prepared to approve the drug using the existing dataset and not – as some had speculated – require additional clinical trials, despite the fact that the drug is already sold (as Servier’s Procoralan) for CHF and also stable angina in Europe.
Amgen acquired US rights to ivabradine from Servier last year and the drug represents the first foray for Amgen into the cardiovascular category.
Aside from having reasonable sales potential in its own right – analysts have predicted it could make $500m a year in the US – ivabradine will also help the company prepare for the potential launch of evolocumab, a PCSK9 inhibitor for hyperlipidaemia that – if some are to be believed – could eventually bring in 10 times that figure.
Amgen’s head of commercial operations Tony Hooper said recently the company was setting up the team that will handle the ivabradine launch and this unit “will be the same organisation that then takes evolocumab to market a bit later during 2015.”