Cel­gene can breathe a sigh of re­lief as FDA ac­cepts once-spurned ozan­i­mod ap­pli­ca­tion — set­ting a tar­get date on a block­buster de­ci­sion

For most ma­jor bio­phar­mas, hav­ing your NDA ac­cept­ed for re­view is a non-event. At Cel­gene and Bris­tol-My­ers Squibb this morn­ing, it’s cause for cel­e­bra­tion.

The big biotech re­port­ed that both the FDA as well as the EMA have ac­cept­ed their ap­pli­ca­tion for ozan­i­mod, an ex­per­i­men­tal ther­a­py for mul­ti­ple scle­ro­sis. That’s by no means a guar­an­tee of ap­proval, but it does set the clock tick­ing on a ma­jor reg­u­la­to­ry de­ci­sion that is cen­tral to the suc­cess of the $74 bil­lion Cel­gene buy­out by Bris­tol-My­ers Squibb.

The PDU­FA date on this one now sits with a March 25, 2020 dead­line for the key reg­u­la­to­ry de­ci­sion in the US. The EMA’s an­swer will come in the first half of next year.

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