Amgen's ($AMGN) new cholesterol fighter may be second in line for FDA approval in the U.S. But in Europe, it's officially first. Amgen's PCSK9 contender Repatha slipped past Sanofi ($SNY) and Regeneron's ($REGN) Praluent to win E.U. approval Tuesday, with a broad label that could help it build sales quickly.
The European approval puts Amgen two months ahead of its rival in that market. Praluent is up for an expert panel recommendation later this week, but full European Commission approval wouldn't come for a couple of months after that.
The U.S. market is most important to the PCSK9 race, however, because new drugs are quickly covered by U.S. payers, and sales can ramp up from there. In Europe, drugmakers face country-by-country rollouts, with price negotiations in each market, a process that delivers slower uptake. Plus, U.S. prices are typically higher, even as payers crack down on expensive drugs.
And in the U.S., Sanofi and Regeneron have the lead, thanks to a priority review voucher they purchased from BioMarin Pharmaceuticals ($BMRN). That voucher gives Praluent a decision date this Friday, a little over one month ahead of Repatha's, Evercore ISI analyst Mark Schoenebaum said in a note to investors.
It's tempting to conclude that the broad European label for Repatha would indicate, a., a similarly broad label for Praluent there, and b., broad labeling for both in the U.S. But Schoenebaum figures that there's "very little read-across" from the E.U. approval today to the FDA's forthcoming decisions on U.S. labeling.
"That said, we are bullish on [Amgen and Regeneron] receiving a broad label in the U.S.," Schoenebaum said.
The labeling question is an important one because it determines how Amgen, Sanofi and Regeneron can position their drugs--and how many people will be eligible for them from the get-go. An FDA advisory panel last month backed both drugs for approval, but they were most enthusiastic about their use in high-risk patients and in those with extremely high cholesterol. The panelists were more skeptical of their use in patients who aren't eligible for statins or who don't respond adequately to the older meds.
Outcomes due to wrap up next year could make the case for PCSK9 meds in statin-intolerant patients, but Amgen and Sanofi obviously prefer not to wait that long for a broad approval. Because prices are likely to be high for the new class--$8,000 to $10,000 per year--payers won't be eager to cover off-label use, limiting sales prospects for the first couple of years. At least one payer sees the PCSK9 class costing the U.S. health system $23 billion, with much higher costs if use is really broad. Pharma analysts have put yearly sales of the drugs at $3 billion or more.
- read the release from Amgen
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