Plus   Neg

Celgene Says FDA And EMA Accept Applications For Ozanimod

Celgene Corp. (CELG) said Thursday that the U.S. Food and Drug Administration or FDA has accepted for review the New Drug Application for ozanimod for the treatment of people with relapsing forms of multiple sclerosis or RMS in the U.S.

In addition, the European Medicines Agency or EMA has accepted for review the Marketing Authorization Application for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis or RRMS in the European Union.

The FDA and EMA applications are based primarily on ozanimod data from the SUNBEAM and RADIANCE Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial.

Jay Backstrom, Chief Medical Officer for Celgene said, "We believe that ozanimod has the potential to be an important option early in the treatment of relapsing forms of MS and a best-in-class S1P receptor modulator."

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5).

Under the Prescription Drug User Fee Act, the FDA has set its action date as March 25, 2020. Celgene said it expects a regulatory decision from the EMA in the first half of 2020.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
CVS Health Corp. is hiring 15,000 employees across the U.S. in the fourth quarter to better equip them to tackle the anticipated rise in COVID-19 and flu incidences during the fall and winter months. This is in addition to the recruitment announced in March to fill 50,000 new full-time, part-time and temporary roles across the country in support of the company's response to the pandemic. Ireland's Data Protection Commissioner or DPC, the European Union's main data privacy regulator, is investigating Facebook over its handling of millions of children's personal data on Instagram, reports said. The agency has started two separate inquiries regarding information that email addresses and phone numbers of users under 18 were made public by the Facebook-owned app. ConocoPhillips (COP) and Concho Resources (CXO) announced Monday that they have entered into a definitive agreement to combine companies in an all-stock transaction valued at $9.7 billion. The transaction creates a company with an approximately $60 billion enterprise value and a combined resource...
Follow RTT