Amgen's Repatha wins first PCSK9 OK in Japan

Amgen ($AMGN) and the Sanofi ($SNY) and Regeneron ($REGN) team have been duking it out with their PCSK9 meds in the U.S., racing to ink payer deals in an effort to get ahead. But now, Amgen has the chance to get ahead start in another of the world's largest pharma markets.

The California biotech's contender, Repatha, has won approval in Japan, it said Thursday. The drug--developed in the country by Amgen Astellas BioPharma, a joint venture between the two companies--is indicated for those patients who have familial hypercholesterolemia or hypercholesterolemia, are at high risk of cardiovascular events, and can't keep their LDL cholesterol levels under control with statins.

For Amgen, it's the fourth global Repatha approval, following nods in the U.S., Canada and the EU. And it's also a chance to gain ground on Praluent, its Sanofi/Regeneron nemesis that beat it to market in its home country.

Amgen has been doing its best to catch up in the U.S. since getting the green light in late August, though--and so far, it appears to be leading its rival in the quest to secure favor from insurers and pharmacy benefits managers. Express Scripts ($ESRX), one of the country's two largest PBMs, said in October that it would cover both drugs, but the other leading PBM heavyweight, CVS ($CVS), has tagged Repatha as its preferred product. The Thousand Oaks-based company also has an exclusive deal with Harvard Pilgrim Health System, thanks to a pay-for-performance arrangement.

Right now, though, both Repatha and Praluent are being held back by "narrow" labels from the FDA that restrict their use to certain patients. Their makers are hoping that once outcomes data become available down the line, the agency could expand their use--a move that would give sales a lift.

- read Amgen's release

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