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10 Approvals To Watch For In Early 2017

 
• By Alexandra Shimmings

Dupixent, Austedo, brigatinib and Olumiant are among a raft of new drug approvals expected in the first four months of the year. Here, with help from Informa Pharma's Biomedtracker, we take a look at 10 of the more interesting products looking close to reaching the market, some for the second time of asking.

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Dupixent Quick Facts

US PDUFA Date: Mar. 29, 2017

First Review

Breakthrough Therapy Status

EU Approval under review

BMT LOA – Above average 79%

First in class

The increasingly crowded immunology/inflammation market is set to receive some new entrants this year, with Sanofi /Regeneron Pharmaceuticals Inc.'s Dupixent (dupilumab), a potential first-in-class IL4-receptor antibody that inhibits signaling of IL-4 and IL-13, two key cytokines required for the type 2 (including Th2) immune response. The indication under review is atopic dermatitis, but Dupixent is being developed under five different allergic indications, with pivotal Phase III trials in asthma ongoing and filings due by year end. Regeneron believes it has found the “control point” for a variety of allergic diseases and that this drug can be expanded to indications including food allergies.

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