At the beginning of May 2013, Sanofi’s R&D pipeline contains 62 projects (excluding Life Cycle Management) and vaccine candidates in clinical development of which 16 are in Phase III or have been submitted to the health authorities for approval.
An ever-changing portfolio
Since the publication of the full-year results on February 7, 2013, Sanofi received the following regulatory decisions:
- In April, the European Commission approved Sanofi Pasteur’s 6-in-1 pediatric vaccine Hexyon™/Hexacima® (DTaP-IPV-Hib-HepB vaccine) for primary and booster vaccination of infants from six weeks of age.
- In April, a decentralized marketing authorization application was accepted for review in the European Union countries for a quadrivalent (four-strain) formulation of Vaxigrip®, Sanofi Pasteur’s seasonal influenza vaccine. The file has been accepted for review by France’s Agence nationale de sécurité du medicament et des produits de santé (ANSM) as the regulatory agency for the “Reference Member State”, and by national regulatory agencies from the EU countries.
- In March, following Genzyme's request for re-examination, the CHMP of the European Medicines Agency (EMA) confirmed its previous position and maintained a negative opinion regarding the marketing authorization application for Kynamro™ (mipomersen sodium, development partnership with Isis Pharmaceuticals) as a treatment for patients with Homozygous Familial Hypercholesterolaemia (HoFH). The Food and Drug Administration (FDA) approved Kynamro™ in the United States in January 2013 for the treatment of patients with homozygous familial hypercholesterolaemia.
- In March, the CHMP of the EMA issued a positive opinion regarding the approval of once-daily, oral Aubagio® (teriflunomide) for the treatment of adult patients with relapsing-remitting multiple sclerosis (MS). The CHMP did not recommend that Aubagio® receive a new active substance (NAS) designation. Genzyme has requested that the CHMP re-examine the NAS designation.
- In February, the U.S. FDA accepted for review a New Drug Application (NDA) for lixisenatide, a once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes. Lixisenatide was approved in the European Union on February 1, 2013 under the brand name Lyxumia®.
In addition, the results from the landmark ORIGIN trial (Outcome Reduction with Initial Glargine Intervention), were submitted to European and U.S. regulatory agencies. ORIGIN was a seven-year randomized clinical trial designed to assess the effects of treatment with insulin glargine versus standard care on cardiovascular (CV) outcomes. The study involved over 12,500 participants worldwide with pre-diabetes or early type 2 diabetes and high CV risk.
All projects in late phases of development
All projects in early phases of clinical development
Genzyme R&D portfolio
February 7, 2013