1. Scrip
  2. >>New Products

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.

Snowdrops
New Life Springs Forth For Pharma • Source: Shutterstock
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.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from New Products

Pipeline Watch: Ten Approvals And Seventeen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Defying Gravity: Five Drugs That Surpassed Their Sales Forecasts

 
• By Edwin Elmhirst

Many assets outperform their pre-launch sales predictions despite the frequent overestimation of forecasts within the industry. In this article, Scrip highlights several such assets and the factors that influenced their predictions.

Gilead’s Yeztugo Gets US Approval For Twice-Yearly PrEP

 
• By Alexandra Shimmings

The first twice-yearly option for HIV prevention has been approved by the US Food and Drug Administration in an advance that “brings us closer than ever to ending the HIV epidemic,” said CEO Daniel O’Day.

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from Scrip

Chinese Developers Showcase Potentially Differentiated Weight Loss Assets At ADA

 
• By Xu Hu

Multiple Chinese firms presented at this year’s ADA meeting, with a focus on weight reduction efficacy for mostly early clinical stage assets. While limited information was given on lean mass preservation, several companies are progressing drugs and combos to address this need.

Cidara’s Fortunes Improve Quickly With Non-Vaccine Flu-Prevention Data

 
• By Joseph Haas

Having recently abandoned the antifungal space, Cidara’s stock soared on Phase IIb data showing that its drug-Fc conjugate prevents seasonal flu at rates from 57%-76%.

Exelixis Positions Zanzalintinib For Post-Cabozantinib LOE Future

 
• By Alaric DeArment

The company announced positive Phase III data in previously treated colorectal cancer for zanzalintinib and it could see sales of more than $1bn in that indication.