[Ip-health] Regeneron and Sanofi use FDA Priority review voucher for alirocumab

Jamie Love james.love at keionline.org
Mon Jan 26 21:48:47 PST 2015


​
Regeneron and Sanofi are using a purchased FDA priority review voucher
​ (PRV)​
to position a new biologic drug (alirocumab) for the treatment of patients
with the cardiovascular disease hypercholesterolemia ahead of a competing
product
​ ​
(evolocumab) from Amgen.

Both products are human monoclonal antibody PCSK9 inhibitors
​ that​
aim to improve the liver's ability to remove LDL-C ("bad" cholesterol) from
the blood.

Regeneron and Sanofi paid $67.5 million for the FDA priority review
voucher, which was purchased from BioMarin Pharmaceutical Inc.

​The whole process of giving out these priority review vouchers (PRVs) is
designed to distort the timing of FDA approvals, away from scenarios that
depend upon the medical merits of the drugs and the timing of the BLA
submission. ​ It will be interesting to see if the prices for the PRV
change.

​Jamie​


This from the
​Regeneron/Sanofi
press release
​:​


http://www.prnewswire.com/news-releases/regeneron-and-sanofi-announce-praluent-alirocumab-biologics-license-application-has-been-accepted-for-priority-review-by-us-fda-300025157.html

Regeneron and Sanofi Announce Praluent™ (alirocumab) Biologics License
Application has Been Accepted for Priority Review by US FDA

TARRYTOWN, N.Y. and PARIS, Jan. 26, 2015 /PRNewswire/ -- Regeneron
Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the
U.S. Food and Drug Administration (FDA) has accepted for priority review
the Biologics License Application (BLA) for PraluentTM (
​​
alirocumab). Under the Prescription Drug User Fee Act (PDUFA), the goal for
a priority review is six months, for a target action date of July 24, 2015.
Alirocumab is an investigational monoclonal antibody targeting PCSK9
(proprotein convertase subtilisin/kexin type 9) that is intended for the
treatment of patients with hypercholesterolemia.

The BLA for Praluent contains data from more than 5,000 patients, including
10 Phase 3 ODYSSEY trials. Together with additional ongoing studies
including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include
more than 23,500 patients at more than 2,000 study centers in double-blind,
randomized, placebo-and active-controlled trials ranging from 24 weeks to
approximately 5 years.

Earlier this month, the companies announced that the European Medicines
Agency (EMA) accepted for review the Marketing Authorization Application
for Praluent in the European Union. The EMA and FDA have conditionally
accepted Praluent as the trade name for alirocumab. The safety and efficacy
of alirocumab have not been fully evaluated by any regulatory authority.

This is the biocentury story:

http://www.biocentury.com/dailynews/company/2015-01-26/voucher-puts-alirocumab-ahead-in-pcsk9-race

Voucher puts alirocumab ahead in PCSK9 race
Monday, January 26, 2015

FDA accepted and granted Priority Review to a BLA for Praluent alirocumab
from Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi (Euronext:SAN;
NYSE:SNY) to treat hypercholesterolemia.

Praluent's PDUFA date is July 24, more than one month ahead of that of
evolocumab (AMG 145) from Amgen Inc. (NASDAQ:AMGN). Both are human mAbs
against proprotein convertase subtilisin/kexin type 9 (PCSK9). Evolocumab's
PDUFA date is Aug. 27 (see BioCentury Extra, Nov. 10, 2014).

Regeneron and Sanofi used a Priority Review voucher purchased from BioMarin
Pharmaceutical Inc. (NASDAQ:BMRN) to expedite Praluent's review (see
BioCentury, Aug. 4, 2014).

EMA accepted an MAA for Praluent earlier this month to treat
hypercholesterolemia (see BioCentury Extra, Jan. 12).

Regeneron and Sanofi are co-developing Praluent under a 2007 deal.

Regeneron added $3.56 to $423.77 on Monday. Amgen lost $0.08 to $159.73.


See also:
http://www.thepharmaletter.com/article/sanofi-and-regeneron-s-praluent-bla-gains-priority-review-from-us-fda




--
James Love.  Knowledge Ecology International
http://www.keionline.org/donate.html
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love



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