Lilly Breathing Down Amgen/Novartis's Necks With Three Phase III Migraine Wins
Lilly will seek FDA approval in the second half of 2017 for CGRP inhibitor galcanezumab based on three positive Phase III studies – within months of a filing for Amgen's and Novartis's CGRP inhibitor erenumab.
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The company intends to seek US FDA approval in the first half of 2019 for its CGRP inhibitor and believes that liver toxicity previously associated with oral drugs in this class are not a problem for its candidate ubrogepant.
Novartis and Amgen are trying to build a compelling case for the value of their CGRP antagonist erenumab. Novartis said one strategy under consideration is to underwrite the cost of the drug for patients who don't respond.
Lilly will save $500m annually starting in 2018 after $1.2bn in layoff-related costs to reinvest in new products. Also, Cytori halves its headcount; VC OrbiMed closed a $551m Asia fund; and Insmed capitalizes on positive data.