LAUSR

With one full quarter still to go before the end of the year, 41 novel drugs have already been approved by the FDA, putting 2018 on track to surpass 1996’s record 53 new drug approvals. Many of the 21 products approved in Q3 (TABLE 1) were also in areas of unmet need, often with first-in-class mechanisms of action. Among these, Alnylam’s patisiran ensured its place in history as the first FDA-approved RNA interference drug, for the rare disease hereditary transthyretin-mediated amyloidosis. AstraZeneca’s first-in-class CD22-directed cytotoxin, moxetumomab, was the first new treatment for relapsed or refractory hairy cell leukaemia in more than 20 years. Agios and Kyowa Hakko Kirin also gained first-in-class oncology approvals with ivosidenib, an isocitrate dehydrogenase 1 inhibitor, and mogamulizumab, a CC-chemokine receptor 4 monoclonal antibody (mAb), respectively, while Sanofi and Regeneron celebrated the approval of the PD1-specific mAb cemiplimab, the first treatment for metastatic cutaneous squamous cell carcinoma (although it is the sixth immune checkpoint inhibitor to be approved). Completing the six cancer drugs to receive a green light in Q3 were two kinase inhibitors; Pfizer’s dacomitinib was approved for metastatic non-small-cell lung cancer and Verastem’s duvelisib was approved for several blood cancers. Outside of oncology, two mAbs targeting calcitonin-gene-related peptide (CGRP) were approved for migraine: Teva’s fremanezumab and Eli Lilly’s galcanezumab. These follow Amgen/Regeneron’s CGRP receptor-targeted mAb erenumab earlier this year, intensifying competition in this new market. R E G U L ATO RY WAT C H