LIKE REPATHA, PRALUENT NOW HAS CV OUTCOMES DATA IN ITS US LABEL.
With cardiovascular risk-reduction language added to the product’s US label, Sanofi and partner Regeneron Pharmaceuticals Inc.hope Praluent is now better positioned to compete with rival PCSK9 inhibitor Amgen Inc.’s Repatha, which nabbed an outcomes claim in December 2017. Further, the two companies may now hold an edge over the better-selling Repatha as the label update also includes data suggesting an all-cause mortality benefit.
The US FDA cleared the label expansion on 26 April, the same day Sanofi reported that Praluent (alirocumab) yielded disappointing sales of $64m during the first quarter of 2019.
The PCSK9 class came to market in 2015 with high expectations, but sales for the drugs have disappointed due to payer pushback related to initial pricing of approximately $14,000 a year. (Also see "Regeneron: PCSK9s Drowning In Paperwork" - Scrip, 5 May, 2016.) More recently, payers have eased restrictions based on outcomes data and lower prices. (Also see "Sanofi/Regeneron Cut Praluent List Price As PBMs Look To Maintain Rebate Status Quo" - Scrip, 12 Feb, 2019.)
Amgen got a leg up in the competition when its Repatha (evolocumab) obtained a CV risk-reduction label claim from the US FDA in late 2017, based on its outcomes trial, FOURIER, which found that the drug was associated with a 15% reduction in risk for a composite endpoint of cardiovascular outcomes. (Also see "Outcomes Claim May Help Amgen Make Case For PCSK9 Inhibitor Repatha" - Scrip, 1 Dec, 2017.)
Amgen has enjoyed a nice uptick in Repatha business following its CV outcomes claim. Repatha yielded full-year sales of $550m (up 72%) during 2018, significantly higher than the roughly $280m (€250m) brought in by Praluent. In March, the big biotech said it is launching a new CVOT study called VESALIUS-CV that offers the potential to increase the drug’s addressable treatment population by roughly 4.5 million in the US. (Also see "New CV Outcomes Study May Mean Big Boost For Amgen's Repatha Market" - Scrip, 15 Mar, 2019.)
Sanofi/Regeneron followed with the ODYSSEY Outcomes trial results in 2018. (Also see "PCSK9 Inhibitor Labeling Parity Is Within Reach As Praluent And Repatha Strive To Make Commercial Case" - Pink Sheet, 20 Aug, 2018.) It now remains to be seen whether Praluent can get the same boost in sales.
The ODYSSEY Outcomes study demonstrated in 18,924 patients who experienced acute coronary syndrome within a year of enrollment and were randomized equally to Praluent or placebo on top of statin therapy that Praluent produced a 15% reduced risk for major cardiovascular events (p=0.0003). The study’s primary endpoint measured time to first heart attack, stroke, death from coronary disease or unstable angina requiring hospitalization.
The new indication is based on those data, but the updated label also includes other data from ODYSSEY Outcomes that Sanofi/Regeneron can cite, including an all-cause mortality benefit.
The study also demonstrated a 15% reduced risk of all-cause mortality (p=0.026), which could prove a notable differentiation for Praluent compared to Repatha, which does not have a mortality benefit in its label. The trial also showed a 27% reduced risk of stroke, a 14% reduced risk of non-fatal heart attack and a 39% reduced risk of unstable angina requiring hospitalization. "Because statistical testing of these endpoints was performed outside of the [trial's prespecified] hierarchy, the results are not considered statistically significant," the company explained. The all-cause mortality data is included in a table of the outcomes results, with the caveat that it is not statistically significant.
Patients in the outcomes study were assessed for a median of 2.8 years, some up to five years. Roughly 90% of those enrolled were on high-intensity statin therapy prior to randomization. Adverse event rates were similar between the treatment and placebo groups, the companies said, except for injection-site reactions, which occurred in 3.8% of those who received Praluent and 2.1% who received placebo.
Total sales of Praluent came to €56m (about $64m) during the quarter, up 10.2% overall, but US sales declined 26.9%. The impact of rebates to reduce the price more than offset the healthy growth in prescriptions for the cholesterol-reducing drug. (Also see "Dupixent And Vaccines Dominate As Sanofi Profits Rise" - Scrip, 26 Apr, 2019.)
Sanofi executive VP of primary care Dieter Winand noted on the firm’s 26 April earnings call that Praluent tallied 53% growth in US total prescriptions during the first quarter, but that the impact of that volume growth was diminished by rebating, such as the formulary placement agreement it and Regeneron signed with Express Scripts Holding Co.last May. (Also see "Let's Make A Deal: Sanofi/Regeneron Extend A Hand On Praluent, Express Scripts Takes It" - Scrip, 1 May, 2018.) The companies followed Amgen’s lead in February by slashing the list price of Praluent by 60% to $5,850 per year, at par with Repatha’s pricing. (Also see "Sanofi/Regeneron Cut Praluent List Price As PBMs Look To Maintain Rebate Status Quo" - Scrip, 12 Feb, 2019.) In tandem with that, Praluent obtained an updated Medicare new drug code (NDC) in February.
Winand said those moves were made in recognition that “it was very important that we maintain very broad access to realize the full potential of the product going forward.” He cited the new cholesterol-reduction treatment guidelines released by the American Heart Association and the American College of Cardiology last November – which said the PCSK9 class offered minimal therapeutic value compared to its pricing – as putting additional pressure on Praluent. (Also see "New US Cholesterol Guidelines Hit PCSK9s Hard On Pricing, Value" - Scrip, 19 Nov, 2018.)
“The outlook for Praluent in the US is more volume growth going forward, offset by continued price pressure to maintain the access,” the exec said, “while in Europe, we have seen very good growth in Europe with a 53% increase via Praluent. We expect that to continue going forward.”
In an April 26 note, BMO Capital Markets analyst Matthew Luchini pointed out that Praluent first quarter sales were well below consensus estimates of $89m. Noting the impact of pricing pressure in the US, the analyst said, “we continue to expect label expansion in the US for reducing CV events in the second quarter of 2019 to inject growth into the drug.”
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