Table.
Phase 3 Drug Pipeline for Multiple Sclerosis
| Nonproprietary name | Manufacturer | Indication | Drug category | Estimated FDA submission date |
|---|---|---|---|---|
| Daclizumab high-yield process | Biogen Idec and AbbVie | RRMS | Interleukin-2 inhibitor | April 29, 2015 |
| Masitinib | AB Science | PPMS, SPMS | Tyrosine kinase inhibitor | 2017 |
| Laquinimod | Teva and Active Biotech | RRMS | Immunomodulatora | 2017 or beyondb |
| Ponesimod | Actelion | RRMS | Sphingosine-1-phosphate receptor 1 inhibitor |
2018 |
| Siponimod | Novartis | RRMS, PPMS, SPMS | Sphingosine-1-phosphate receptors 1 and 5 inhibitor | 2017 |
| Ozanimod | Celgene | RRMS, PPMS, SPMS | Sphingosine-1-phosphate receptors 1 and 5 inhibitor | 2018 |
| Ocrelizumab | Genentech | PPMS, SPMS | CD20-positive B-cell–targeting monoclonal antibody | 2016 |
a
Mechanism of action has not been fully elucidated.
b
New drug application was originally planned in February 2012, but Teva decided not to submit at that time. FDA News. Teva withholds NDA for MS drug laquinimod following FDA talks. February 22, 2012. www.fdanews.com/articles/144195-teva-withholds-nda-for-ms-drug-laquinimod-following-fda-talks.
PPMS indicates primary progressive multiple sclerosis; RRMS, relapsing-remitting multiple sclerosis; SPMS, secondary progressive multiple sclerosis.