* Sanofi to file drug for US and EU approval by year-end
* Nine Phase III ODYSSEY trials meet primary endpoint
* Alirocumab "generally well tolerated" in trials
By Natalie Huet
PARIS, July 30 A new drug being developed by
French drugmaker Sanofi and U.S. partner Regeneron
cut "bad" LDL cholesterol more than placebo and
existing treatments in nine late-stage clinical trials, the
companies said on Wednesday.
The injectable drug, called alirocumab, is from a promising
new class of medicines, called PCSK9 inhibitors, also being
developed by Amgen Inc and other drugmakers. If
approved, these drugs could reap annual sales of $3 billion or
more, according to some industry analysts.
The Phase III ODYSSEY trials showed that after 24 weeks, the
mean percentage reduction in LDL cholesterol with alirocumab was
consistent with results seen in previous trials, the companies
said in a statement.
The trials involved patients whose high LDL cholesterol
levels are not sufficiently controlled by existing treatments
such as statins, who cannot tolerate these or who present a high
or very high cardiovascular risk.
"The robust data from these studies in more than 5,000
patients is the basis of our global regulatory submissions,
which we expect in the U.S. and EU by year-end," said Sanofi R&D
chief Elias Zerhouni.
PCSK9 inhibitors block a protein that prevents the body from
eliminating LDL cholesterol from the bloodstream and offer a new
way of fighting the build-up of artery-clogging fat that puts
patients at risk of heart attacks.
These drugs are mainly aimed at the millions of people who
either cannot tolerate statins such as Pfizer Inc's
Lipitor or AstraZeneca Plc's Crestor or who cannot get
their cholesterol levels under control with statins alone.
In earlier mid-stage studies, when combined with statins,
alirocumab and Amgen's own PCSK9 drug cut levels of LDL
cholesterol by close to 70 percent, more than statins alone.
The drug was "generally well tolerated" in the trials, with
most common adverse events being nasopharyngitis, upper
respiratory tract infections and injection site reactions.
Serious adverse events and deaths were "generally balanced"
between treatment groups as were musculoskeletal, neurocognitive
and liver-related events, the companies added.
An interim safety analysis showed that after 18 months of
treatment, patients on alirocumab were less prone to
cardiovascular events (cardiac death, myocardial infarction,
stroke, and unstable angina requiring hospitalization) compared
with those on placebo.
Alirocumab's potential to cut cardiovascular risk is being
assessed in an ongoing 18,000-patient long-term outcomes trial.
(Editing by Mark Potter)