Pfizer's PCSK9 drug notches two Phase 3 wins
- Pfizer on Tuesday said its investigational PCSK9 drug lowered LDL-C levels (so-called “bad” cholesterol), meeting its main goal in two Phase 3 trials.
- Pfizer has set up an ambitious series of six lipid-lowering Phase 3 trials plus two cardiovascular outcome studies for the drug, bococizumab, in hopes of catching PCSK9 market leaders Amgen and Sanofi/Regeneron.
- Uptake of Amgen’s Repatha and Sanofi/Regeneron’s Praluent has been slow, as payers have balked at the high cost of the drugs.
Physicians’ expectations were high last summer when Repatha and Praluent launched.
The drugs, which lowered LDL-C by roughly 60% in clinical trials, could provide an important new option for physicians attempting to treat patients intolerant of statins or with unmanageable cholesterol levels.
Yet uptake was slow as payers scrutinized the $14,000 per year price tag and target population.
Amgen and the Sanofi/Regeneron team have been aggressive in trying to boost the drugs’ profile. Both have signed pay-for-performance deals with the major U.S. health insurer Cigna, linking price to patient-outcomes.
If bococizumab makes it to market, Pfizer would be the third fiddle to an already tough market. But the company hopes it can distinguish bococizumab by demonstrating a cardiovascular benefit.
The remaining two lipid-lowering studies are expected to finish later in 2016, while the cardiovascular outcomes studies will report in the second half of next year, according to FiercePharma.
Amgen appears to have the upper hand right now, but next year could prove to be competitive if bococizumab continues its string of trial successes.