Am­gen and No­var­tis ID the fin­ish line in a wicked scram­ble for first CGRP mi­graine drug OK

Am­gen and its part­ners at No­var­tis are one step clos­er to field­ing a new mi­graine drug in the US. The phar­ma gi­ants said Thurs­day af­ter­noon that the FDA has ac­cept­ed their ap­pli­ca­tion for erenum­ab, the fur­thest ad­vanced CGRP ther­a­py which is now nav­i­gat­ing to­ward a May 17 PDU­FA date.

The com­pa­nies have now dubbed the drug Aimovig, with piv­otal da­ta from 2,600 pa­tients.

This is like­ly go­ing to be quite a crowd­ed field, though, with a line­up of de­vel­op­ers po­si­tion­ing their own late-stage prod­ucts for the last leg of the race through the agency. And the da­ta so far in­di­cate that sev­er­al of these new drugs will look a lot alike.

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