* Priority review status means FDA decision within 10 mths
* Eliglustat annual sales seen at $517 mln by 2018-analysts
PARIS Dec 11 French drugmaker Sanofi
said U.S. authorities had decided to carry out a priority review
of its experimental pill for patients with Gaucher disease.
The Food and Drug Administration (FDA) will now rule on
whether to approve eliglustat for the treatment of the rare
genetic disorder within six months instead of 10, Sanofi said in
a statement on Wednesday.
Patients with Gaucher disease, which affects fewer than
10,000 people, are deficient in an enzyme that breaks down a
certain type of fat, leading to potentially life-threatening
organ damage and bone problems.
The FDA grants priority reviews to medicines that are
considered to offer a major advance in treatment or address an
unmet medical need. The European Medicines Agency validated a
marketing authorisation application for eliglustat in October.
Twice-daily capsule eliglustat could become the first oral
treatment for Gaucher disease and shake up the market for
therapies that currently have to be injected bi-weekly.
Analysts expect eliglustat to reap annual sales of $517
million by 2018, according to forecasts compiled by Thomson
Sanofi also makes Cerezyme, an injectable treatment which
for many years dominated the Gaucher disease market and was at
one point the most expensive drug in the world, costing more
than $200,000 a year.
Other current treatments include Shire's Vpriv and