NEW YORK & CHICAGO--(BUSINESS WIRE)--Link to Fitch Ratings' Report: Global Pharmaceutical R&D Pipeline
(Diverging Trends for Cholesterol-Lowering Drugs)
Clinical outcomes data on two approved cholesterol drugs, Amgen's Repatha and Sanofi/Regeneron's Praluent, could pave the way for approvals of other similar-acting drugs in the pipeline, according to a Fitch Ratings special report.
"Although Repatha and Praluent are already considered breakthrough therapies for hard-to-treat patients, the ability to demonstrate clinical benefits beyond just cholesterol reduction could solidify the commercial prospects for the entire class," said Bob Kirby, Director, U.S. Corporates.
In particular, it could spur physician prescriptions and payer reimbursements, and potentially open a door for similar-acting drugs like Pfizer's tanezumab, Johnson & Johnson's fulranumab and Regeneron's fasinumab.
However, not all classes of cholesterol drugs have such bright prospects.
Only one cholesteryl ester transfer protein inhibitor, Merck's anacetrapib, remains in late-stage development. Others including Eli Lilly's evacetrapib, Pfizer's torcetrapib and Roche's dalcetrapib, were precluded from regulatory submission due to insufficient clinical safety and efficacy results that negatively impact the probability of success for Merck's anacetrapib.
Separately, the FDA withdrew approvals for the branded and generic version of two cholesterol drugs, Advicor and Simcor, citing a risk-benefit analysis that no longer weighed in patients' favors.
"Clinical trials have always provided critical data points that shape the pharmaceutical industry, but these cholesterol drug trials demonstrate how they can make or break entire classes of innovative therapies," said Kirby. "With the shift to value-based healthcare in all parts of the industry, this dynamic is probably here to stay."
The full report, "Global Pharmaceutical R&D Pipeline: Diverging Trends for Cholesterol-Lowering Drugs," is available at www.fitchratings.com
Additional information is available on www.fitchratings.com.