December 11, 2013 / 7:30 AM / 4 years ago

Sanofi Gaucher pill application gets priority FDA review

PARIS (Reuters) - 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 authorization 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 Reuters Cortellis.

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 Pfizer’s Elelyso.

Reporting by James Regan and Natalie Huet; editing by Tom Pfeiffer

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below